GENERAL DIRECTORATE OF TREATMENT SERVICES

DEPARTMENT OF BIOMEDICAL ENGINEERING SERVICES 

COMPLIANCE WITH EU TECHNICAL LEGISLATION AND

NATIONAL PROGRAM

WITHIN

"MEDICAL DEVICES LEGISLATION’

 
 

        FREE
MOVEMENT OF GOODS 

• Cosmetics
• Drugs and Psychotropic Substances
• Medical Devices
• Active Medical Devices That Can Be Placed In The Body
• Medical Diagnostic Devices Used Outside The Body (In Vitro)
• Toys
• Eatables
• Detergents

 
 

LEGAL BASIS 

• “Basis of Medical Device Regulations, Law No. 4703 " on the preparation and implementation of technical legislation on products”

 

- “Basic Law on health services " No. 3359 is “Decree Law on the organization and duties of the Ministry of Health”No. 181. 

 
 

CONTRIBUTIONS OF THE LEGISLATION 

• The Legal Gap Has Been Filled.
• Consumer Rights Were Protected By Making The Manufacturer Directly Responsible.
• The ministry will carry out market surveillance and supervision of products released in the health sector.
• The devices will undergo various testing and certification stages.
• The ministry will appoint Notified Bodies and oversee testing and certification Laboratories.

 
 

WHAT DOES REGULATION BRING? 

    In order for devices that fall within the scope of the regulation (except for bespoke and clinical research devices) to be included in the market, they are required to bear the CE mark.

   

    Accordingly, as of the effective date of the Regulation (31 December 2003) medical devices are defined as all devices (except for clinical research purposes, with bespoke manufactured appliances) on the market conformity assessment process before being placed through the patient, the practitioner, and must carry the CE mark which means a safe product to third parties. 
 

 
 

               
 

"CE MARKING” 

                                                             

 
 

    CE ;

    It is a sign of conformity with the new approach directives of the European Union, showing that the product attached to it is safe for HUMAN, ANIMAL and ENVIRONMENT.

 
 

CE; letters in French,  

"EUROPENNE CONFORMITE”

expressed as and compliance with Europe,

marking and evaluation system

description

 
 

"CE Mark”  

    It serves as a kind of passport so that products can be released into free circulation in EU member states. 

    It is not a quality brand or product brand by itself. Therefore, TSE cannot be used instead of brands such as TÜV.

 
 

    The European Union began the implementation of the CE mark in 1985. 

    In Turkey, 11.01.2002 date and 24643 entered into force with the Official Gazette, 14.02.2004 date and 25373 began to be published in the Official Gazette.

 
 

    The CE conformity mark must be at least 5 mm high in size.  

    The CE Mark must be placed on the product, and in cases where this is not possible, on its packaging. 

 
 

    As part of the new approach directives and policy of the European Union, there are 24 directives that require the CE mark so far, and the main product groups are;

• Toys
• Construction Materials
• Low Voltage Devices
• Machines
• Medical Devices
• Freezers
• Telecommunication Devices

 
 

NOTIFIED BODY 

    Notified Body, 

    From among the test inspection and/or certification bodies, to participate in conformity assessment activities within the framework of Medical Device Regulations,  

    In the "Law on Preparation and Implementation of Technical Legislation on Products" dated 29.06.2001 and numbered 4703, regulations and  

 It is a public or private organization authorized within the framework of the "Regulation on Conformity Assessment Bodies and Notified Bodies" published in the Official Gazette dated 17.01.2002 and numbered 24643 and in the framework of the criteria set out by the General Directorate of Treatment Services. 

 
 

    Internet address of Notified Bodies operating in the field of Medical Devices in the European Union; 
 

    http://europa.eu.int/comm/enterprise/newapproach/legislation/nb/notified_bodies.htm 

NOTIFIED BODY

 
 

MEDICAL DEVICE REGULATION 93/42/EEC

 
 

• Directive 90/385 / EEC:
  Active Implantable Medical Devices

 

• Directive 93/42/EEC:
  Medical Devices

 

• Directive 98/79/EC:
   Medical Diagnostic Devices Used Outside the Body (In Vitro Diagnostic Medical Devices)

 

THREE BASIC DIRECTIVES ON MEDICAL DEVICES

 
 

ACTIVE MEDICAL DEVICE THAT CAN BE PLACED ON THE BODY 

Devices that are supposed to be permanently placed in the human body and are a power source for it to perform its function. 

Examples:

• Pacemakers,
• Diffusion pumps used in oncological applications,

 
 

MEDICAL DIAGNOSTIC DEVICES USED OUTSIDE THE BODY 

• Reagent (Myar - separator) or reagent product,
• Calibrator, control material, kit,
• Device, apparatus, equipment or system,

and samples taken from the human body,

• A psychological or pathological condition,
• An inherited abnormality
• Safety and compliance with potential buyers,
• Treatment measures

These are the devices intended to be used outside the human body in order to obtain information about it.

 
 

MEDICAL DIAGNOSTIC DEVICES USED OUTSIDE THE BODY 

  Examples:

• Reagents used in pregnancy testing,
• Reagents used to determine blood type,
• Reagents used in AIDS diagnosis,
• Sample containers used for transporting and preserving human body samples

 
 

Does not provide its primary function when used in humans with pharmacological, chemical, immunological or metabolic effects;

but can be supported by these effects while performing its function,
- diagnosis, prevention, monitoring, treatment
or alleviation of a disease in humans;
 - diagnosis, monitoring, treatment,
 mitigation or relief of an injury or grievance;
- research, alteration or substitution of an anatomical or
physiological function;
contraception;
 is any tool, device, tool, material or other material produced for the purpose, that can be used alone or in combination, and also used with computer software if necessary to fulfill its intended function. 

MEDICAL DEVICE

 
 

Examples:

• Anastesis equipment, MRI equipment, sterilizer, surgery equipment, etc. hospital equipment,
•   Dental hand tools, dental implants and materials (including amalgam and porcelain), hardeners,
• Measurement and diagnostic devices, glasses and lenses used in surveillance,
• Ear prosthesis, hearing aid, etc. audio metric devices,
• Artificial muscle, hip implant, walking support, corset etc. implant or non-implant prostheses,
• Disabled vehicles such as wheelchairs and rehabilitation equipment,
• Disposable items such as latex gloves, surgical drapes, tampons.

 

MEDICAL DEVICE

 
 

OUT OF SCOPE PRODUCTS 

• Products covered by 65/65/EEC and 89/381/EEC,
• Cosmetics covered by 76/768/EEC,
• Human blood, blood products, plasma and blood cells,
• Human or animal origin transplant, tissue or cells,
• Personal protective equipment covered by 89/686/EEC

 

MEDICAL DEVICE

 
 

ANNEX 1: BASIC REQUIREMENTS

- General Requests:

• High level of health and safety protection,
• Production in accordance with safety principles, at the level of technology,
• Ensuring projected performance,
• Clinical environment and safety of patients are not adversely affected,
• Avoid adverse effects of prescribed use during transport and storage,
• Acceptable level of risks associated with unwanted side effects

- Other Requests:

• Chemical, physical and biological properties,
• Infection and microbial transmission,
• Production and environmental features,
• Devices with measurement function,
• Protection against radiation,
• Devices that are connected to an energy source or that are its own energy source,
• Information provided by the manufacturer

 

MEDICAL DEVICE

 
 

SPECIAL PURPOSE DEVICES 

• Devices to be used for clinical research purposes

  (Article 15 and Annex VIII) 

• Customer specific order devices

  (Article 11 and Annex VIII)  
 

CE MARKING WILL NOT BE PERFORMED ON THESE DEVICES ! 

MEDICAL DEVICE

 
 

Devices according to medical devices directive 93/42/EEC, 

Class I (Low Risk),

Class IIa (Medium Risk),

Class IIB (Medium Risk),

Class III (High Risk) 

it is divided into 4 main classes.  
 

The directive explains how to classify products. 

CLASSIFICATION OF MEDICAL DEVICES

 
 

2 BASIC CRITERIA USED IN CLASSIFICATION: 

I. Occupancy

Temporary use (less than 60 Minutes)

Short-term use (less than 30 days)

Long-term use (longer than 30 days) 

II. Invasive Status

Invasive device : a device inserted into the body through a body opening or from the body surface,

Surgical invasive device : invasive device inserted into the body by surgical intervention,

Implant device: a device that is surgically inserted into the human body and is intended to be permanent (at least 30 days). 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES 

I. Rules for Non-invasive devices (rule 1-4) 

Rule 1: all non-invasive devices are Class I (with exceptions). 

Rule 2: non-invasive devices used to receive, give or store blood, body fluids or tissues, and to release liquids or gases into the body are Class IIA. 

Rule 3: all non-invasive devices used to regulate the biological and chemical compositions of blood, body fluids, or other liquids to be distributed to the body are Class IIB.

If these devices are used for filtration, centrifuge or gas exchange purposes, they are Class IIA. 

Rule 4: all non-invasive devices in contact with injured skin,

               - If used for compression or absorption of leaks, Class I

               - But if it is to be used in the process of wounds that will heal with a procedure, Class IIB

               - In other cases, Class IIa 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES

II. Rules About Invasive Devices (Rule 5-8) 

Rule 5: from devices compatible with body orifices that are not surgical invasive devices and are not combined with other active devices,

• Devices for Temporary Use Class I,
• Devices for short-term use class IIa. (However, Class I is used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum)
• Devices for long-term use Class IIB. (However, Class IIA is used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum, which is not suitable for absorption from the mucous membranes and is used in the oral cavity up to the pharynx)
• Class IIa, all invasive devices compatible with body entrances intended for use in conjunction with an active medical device class IIa or higher, other than surgical invasive devices.

 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 6: all surgical invasive devices prescribed for temporary use are Class IIA. 

- Devices that basically diagnose, monitor and correct a disorder in the heart or central circulatory system by directly contacting these parts of the body are Class III.

- Reusable surgical devices Class I.

- Devices that provide energy in the form of ionizing radiation Class IIB. 

- Devices with biological effect, all or most of which are absorbed Class IIB.

- If, these invasive devices give medication through a release mechanism

convenient and Hazardous Devices Class IIB. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 7: all surgical procedures prescribed for short-term use are invasive, except in the following cases

the devices are Class IIA.

- Devices that basically diagnose, monitor and correct a disorder in the heart or central circulatory system by directly contacting these parts of the body are Class III.

- Devices used especially by direct contact with the central nervous system Class III.

- Devices that provide energy in the form of ionizing radiation Class IIB.

- Devices with biological effect, all or most of which are absorbed Class III.

- Devices that undergo chemical changes in the body or are used to deliver drugs, except those that are inserted into the tooth. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 8: Except for the following situations, all implant devices and surgical invasive devices that are expected to be used for a long time are Class IIb.  

- Devices that are placed on teeth and whose retention is ensured by teeth and / or gum tissue Class IIa.

- Direct contact with the heart, Central circulatory system or central nervous system

devices used are Class III.

- Devices with biological effects or absorbed in all or most of them are Class III.

- Devices that undergo chemical changes in the body or used for drug delivery, except those placed in teeth, are Class III.  

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES 

III. Additional Rules Regarding Active Medical Devices (Rule 9-12) 

Rule 9: All active therapeutic devices for energizing or providing energy conversion are Class IIa. However, considering its structure, density and energy application location, those who pose a potential risk in the human body in giving and receiving energy or providing energy conversion fall into Class IIb.

Devices that monitor and control the performance of active therapeutic devices in Class IIb or active medical devices intended to directly affect the performance of these devices are also Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 10: The following diagnostic active devices fall into Class IIa:

- Devices that provide energy to be absorbed by the human body, except devices used to illuminate the patient's body in a visible spectrum,

- Devices used to display the distribution of radiopharmaceuticals in living tissues,

- Devices that allow direct diagnosis or monitoring of vital physiological functions.

However, those aiming to monitor changes that may cause immediate danger in the patient's condition such as central nervous system activities, changes in respiratory and heart functions are included in Class IIb.

Devices that emit ionizing radiation and devices for interventional radiological diagnosis and treatment and active devices for controlling and monitoring these devices or directly affecting their performance fall into Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 11: All active devices that deliver or take drugs, bodily fluids, and other substances into the body fall into Class IIA. However, considering the method of administration, the relevant part of the body and the nature of the substances administered, if this procedure poses a potential risk, they are in Class IIb. 

Rule 12: All other active devices are in Class I. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES

IV. Additional Rules On Active Medical Devices (Rule 13-18) 

Rule 13: When used separately, all devices that are considered as a medical product and contain a substance that has an activity supporting the effect of the device on human beings as an internal part fall into Class III.

All devices that contain human blood derivative as part of a whole fall into Class III. 

Rule 14: All devices used to prevent the transmission of birth control or sexually transmitted diseases fall into Class IIb. But if it is an implant or an invasive device that is prescribed for long-term use, they fall into Class III. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 15: To disinfect contact lenses, to clean, rinse and moisturize as needed

devices that serve enter Class IIB.

Devices that specifically serve to disinfect medical devices fall into Class IIA.

This rule does not apply to other products that clean medical devices other than contact lenses with physical effect. 

Rule 16: Inactive devices used especially for the purpose of recording X-ray diagnostic images fall into Class IIa. 

Rule 17: Animal tissue or dead tissue, excluding devices intended for contact with healthy skin only

all devices manufactured using their parts fall into Class III. 

Rule 18: Unlike other rules, blood bags fall into Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Annex VII

Technical File 

Vigilance System 

Class-I Device

(non-sterile / non-measuring function) 

Declaration of conformity & CE mark 

CONFORMITY ASSESSMENT PROCESS FOR CLASS-I PRODUCTS 

The manufacturer will monitor Annex VII and prepare a Technical File.

 
 

Class I Device

(sterile / measuring function) 

Annex VII

Technical File 

Vigilance System 
 

Declaration of conformity & CE mark 

Annex V*

EN ISO 13485

(EN 46002) 

Annex VI*

EN 46003 

Annex IV*

Unit Validation 

* sterile / measuring function considerations

 
 

Manufacturer will prepare technical file according to Annex VII

                                                           +

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

or, 

(iii) EC Declaration of conformity in accordance with Annex VI (Product Quality Assurance System) (module D) 
 

Note: instead of all these, the manufacturer may have a full Quality Assurance System according to Annex II. (MODULE H) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS IIa PRODUCTS

 
 

Class IIA Device 

Annex VII

Technical File 
 
 

Declaration of conformity & CE mark 

Appendix V

Vigilance System

EN ISO 13488

(EN 46002) 

Annex VI

Vigilance system en 46003 

Annex II

Technical File

Vigilance System

EN ISO 13485

(EN 46001) 

EkIV

Vigilance System

Unit Validation

 
 

They will do the manufacturer: 

a) complete Quality Assurance System according to Annex II (module H)

(Annex II, Article 4 does not apply in this case – approval of the technical file to the Notified Body -) 

or, 

b) EC type Examination according to Annex III (Module B) 

                                                           +

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

or, 

(iii) EC Declaration of conformity in accordance with Annex VI (Product Quality Assurance System) (module D) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS IIb PRODUCTS

 
 

Class II B device 

Annex III

Type Review 
 
 

Declaration of conformity & CE mark 
 

Appendix V 

Vigilance System

EN ISO 13488

(EN 46002) 

Annex VI

Vigilance System

EN 46003 

Annex II

Technical File

Vigilance System

EN ISO 13485

(EN 46001) 

Annex IV

Vigilance System

Unit Validation

 
 

The manufacturer will: 

a) complete Quality Assurance System according to Annex II (module B)

(Annex II, Article 4 applies in this case – the design file is approved by the Notified Body -) 

or, 

b) EC type Examination according to Annex III (module H) 

                                                           + 

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS III PRODUCTS

 
 

Class III Device 

Annex III

Type Review 
 

Declaration of conformity & CE mark 

Appendix V

Vigilance system EN ISO 13488

(EN 46002) 

Annex II 

Vigilance System

EN ISO 13485

(EN 46001) 

Annex II.4 

Review The Design File 
 
 

Annex IV

Vigilance System

Unit Validation

 
 

MEDICAL DEVICE CONFORMITY ASSESSMENT MODULES 

Annex I-Basic Requirements 

Annex II - EC Declaration Of Conformity (complete Quality Assurance System) (module B)

                   Detailed design documents of the product,

                   Risk analysis,

                   Quality plans,

                   Clinical data and user's guide (Annex X),      

                   etc.a technical document package (Technical File) consisting of is approved by an approved organization.  

Annex III-EC type Examination (module H)

                     Type approval is made by an approved organization. 

Annex IV - EC Verification (Module F)

                    Statistical control of each product or samples to be taken from cafes by an approved organization (applies to products with Type Approval) 

Annex V-AT Declaration Of Conformity (Production Quality Assurance System) (module E) 

Annex VI - EC Declaration Of Conformity (Product Quality Assurance System) (Module D) 

Annex VII-EC Declaration Of Conformity (module A)

                     The Technical File is prepared.                  

 
 

BASIC STANDARDS USED IN PRACTICE 

• General Standards

  - Safety For Medical Devices (Guide 513)

   - Quality Management System (ISO 9000: 2000)

   - Quality Management System specific to medical devices (ISO 13485 :2003) 

• Process Standards

  - Risk management (ISO 14971: 2000)

   - Clinical Research (ISO 14155)   

 
 

•   Electromagnetic Compatibility

  - IEC 601-1-2 

• Bio Compatibility

  - ISO 10993 

• Functional Safety

  - Product group specific standards 

• Labeling and symbols

  - EN 980: 1994-terminology, symbols and information

  - EN 1041: 1995-Information provided by the manufacturer 

• Sterility

  - En 550 (specific standards based on sterilization methods) 

BASIC STANDARDS USED IN PRACTICE

 
 

Annex 2 

EC declaration of conformity 

MDD 

Annex II 

Full Quality Assurance System 

BS EN ISO 9001 plus BS EN 46001 

Annex III 

EC Type-Examination 

Annex IV 

Annex V 

Annex VI 

Annex VII 

Production Quality Assurance 

Product Quality Assurance 

EC Verification 

BS EN 9002 plus BS EN 46002 

BS EN 9003 

Annex 3 

Annex 4 

Annex 5 

Full Quality Assurance System 

EC Type Examination 

EC Verification 

Production Quality Assurance 

BS EN ISO 9001 plus BS EN 46001 

BS EN ISO 9002 plus BS EN 46002 

AIMD 

MDD Annex 

Title 

Applicable EN Standard 

MDD and AIMD annexes

 
 

CERTIFICATE TYPES 

Definition of change21:

• Published (issued)
• Adapted (modified)
• Have been Red (refused)
• Cancelled(withdraw)
• Extended time)
• Refurbished (renewal)

 he  

Notified Body (NB):

• Authorized signature
• EC approval number ……
• Name and address
• Tel / Fax-No.

 

Special conditions of validity, if any 

 

Scope of quality system20 

 

About device17:

• Product category names18

Terminology Code18

• Name / description of model / type
• Serial or batch number

 Representatives16:

• Name
• Address

 Manufacturing:

• Name
• Address

 NB file number reference15 

 

Main text:

• National regulations references13
• Text14

 Name12  

Expiration date11  

Date of issue 10 

 

Certificate number9 

 

Certificate Type

Content

 
 

FOOTNOTES: 

• Single within ⁹ organizations
• ¹⁰ no format is provided for how the data will be presented in the certificate. "Unless there is a specified case in the contract, the validity of the certificate starts from the date of issue." A format will then be stipulated for entries into the EUDAMED (European Data Exchange for Medical Devices) database.
• ¹¹ See: date of publication;last Limited. Recommendation for text: "this certificate is valid for x years from the date of publication.” Maximum 5 years for Annex II and III ( comment / recommendation: requested and required for all certificates)
• ¹² required for identification of Certificate types (e.g. conformity measurement procedure published in certificates covered by the directive where supported by the directives )
• ¹³ use the text “ " MDD ... as presented in national legislation.”

 
 

FOOTNOTES: 

• ¹⁶ if possible, for example, it can be an authorized representative or a responsible representative .
• ¹⁷ either A) or b); c) subject to annex IV.
• ¹⁸ umdns naming if possible
• ¹⁹ one of the following alternatives must be obtained: a) model numbers directly in the certificate or attached to the certificate; b) model list in the files of the approved organization with a link through the NB file reference; all declarations of conformity in the hands of the approved organization. Objective: to clearly show that the product is covered by the NB approval of the relevant certificate.
• ²⁰ regarding the scope of the quality system; for example, the tools or activities covered

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC TYPE EXAMINATION CERTIFICATE

(Directive 93/42/EEC on medical devices Annex III)we declare that directive 93/42/EEC on medical devices to which the signatory below is connected has been examined by a pattern on the device (s) listed below in accordance with the requirements of the national legislation introduced in annex III. We acknowledge that the device(s)listed below comply with the relevant provisions of the directive mentioned above.  

III / 3  

EC DESIGN-EXAMINATION CERTIFICATE

(Medical devices directive 93/42/EEC Annex II Section 4)we declare that the undersigned person that is connected to the medical devices directive 93/42/EEC Annex II Section 4. listed below are according to the requirements of the national legislation which was presented in that the device(s) reviewed on pattern review. We confirm that the device(s)listed below comply with the provisions of Directive 93/42/EEC annex II section 4, which are introduced in the national legislation on medical devices.  

II, 4/2, 4

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC VERIFICATION CERTIFICATE

(Directive 93/42/EEC on medical devices Annex IV)we declare that an EC verification has been made on the series or batches of devices listed below in accordance with the requirements of the national legislation introduced in Directive 93/42/EEC on medical devices to which the signatory below is connected. We acknowledge that the device(s)listed below comply with the relevant provisions of the directive mentioned above.  

IV / 4  

EC CERTIFICATE FULL QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC on medical devices Annex II)we declare that the full quality assurance system referred to below has been examined in accordance with the requirements of the national legislation presented in Directive 93/42/EEC on medical devices to which the signatory below is connected, Annex II (except Section 4). We confirm that this complete quality assurance system complies with the relevant provisions of the directive.  

II, 3/2, 3

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC CERTIFICATEPRODUCT QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC Annex VI on medical devices)we declare that the product quality system mentioned below has been reviewed in accordance with the requirements of the national legislation introduced in Annex VI of Directive 93/42/EEC on medical devices to which the signatory below is affiliated.  We confirm that this product quality system complies with the relevant provisions of the directive.  

VI  

EC CERTIFICATEPRODUCTION QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC on medical devices Annex V)we declare that directive 93/42/EEC on medical devices to which the signatory below is connected has been reviewed in accordance with the requirements of the national legislation introduced in Annex V.  We confirm that this product quality system complies with the relevant provisions of the directive. 

V / 5

 
 

Declaration Of Conformity(1) 

• The manufacturer must issue a written declaration of Conformity before attaching the CE mark to the product.

 

• This declaration must cover a certain number of manufactured products and must be kept by the manufacturer.

 

• Where Annex IV referred to for conformity assessment is used, the group or serial number of the device must be defined.

 
 

Declaration Of Conformity (2) 

Content

• Name Of The Document ("Declaration Of Conformity”)
• Manufacturer name and address
• Name and Address of Authorized Representative
• Generic Name Of The Device
• Description Of The Device
• Attachments used to ensure compliance with the directive
• Reference to authorized institution document(applicable case)
• Identification of authorized institution (applicable case)
• Signature Of The Authorized Person

 
 
 
 

59  

Technical Documentation and Design File

 
 
 
 
 
 

The purpose of technical documentation is to demonstrate compliance with the requirements of the directives.

•   requirements Annex II.3 and Annex III.It was defined in 3 te.Appendix V.3 and Annex VII of MDD.3

 

•   Design files are requested for Class III products. if Annex II is selected for the compliance report process (Annex II.4, MDD).

 

Technical Documentation and Design File

 
 
 
 
 
 

•   General product description including Planned variations
•   Design drawings and calculations,design specifications, definitions, diagrams of parts, accessories, etc.b.

 

•   Techniques used to control and approve design (Annex II).

 

•   If harmonized standards are not used, definitions of solutions used to adapt the necessary basic requirements

 

Prove that the device meets the basic requirements when used with other devices 

Contents (1)

 
 
 
 
 
 

• Definition of sterilization method, approval of sterilization

 

• Data on drug ingredients used in the device
• Information about production methods
• Definition of quality assurance and inspection techniques
• Risk Analysis

 

• Clinical Data

 

Contents (2)

 
 
 
 
 
 

•   Test results and used test equipment(design confirmation & validity)

 

• Labels and instructions for use

 
 

Contents (3)

 
 
 
 
 
 
 

1 Purpose, Target, Revision history

2 Device descriptions and variants

       (Including functional identification, performance, intended use)

3 Design Documentation and design control procedures

• demonstration of compliance with basic requirements
• Case related to annex I of Article 7.4 (Medical Products)

6 identification of Production Process, Quality Assurance

7 Material and parts testing (eg. Packaging)

8 specific product testing (eg. Safety, Sterility, Biocompatibility)

9 User information (instructions, labels, service manuals)

10 Risk Analysis

11 Clinical Data       

Being

 
 
 
 

65  

• Technical documentation should cover all products and be put together for a family of products.

 

• Technical documentation must be updated when changing the product or applicable process or applicable requirements. (ex. Standards, guidelines)

 

•   The approved institution should be informed of significant changes in the quality system or changes in products.

 

Technical Documentation-Requirements (1)

 
 
 
 

66  

• If Annex II is selected in the compliance report activity, only design files are required for class III devices.

 

• Implementation of testing of design files must be by invitation of the approved organization.The application should define design, production and performance

 

• In addition, the application must include the documents specified in Article 3.2 c of Annex II.

 

Design Files (1)

 
 
 
 
 
 

• After a successful design file has been tested, the Design File Certificate will be issued by the Notified Body.

 

• Associated with the MDD design file certificate (Annex II.4, MDD) Annex II.A certificate according to 3 is required to hit the CE mark on the class III product.

 

• Design file changes must be approved by the approved institution.

 
 

Design File (2)

 
 
 
 
 
 

Vigilance System 

 
 
 
 
 
 

Vigilance System 

• Applied in all CE marking Directives for Medical Devices

• AIMDD, MDD, IVDD

It is a system of reporting and evaluating negative events.
(Vigilance Reporting Procedure, Requirement Procedure)

 
 
 
 
 
 

Purpose Of The Vigilance System 

• Protecting community health and safety
• Preventing accidents from happening again by evaluating
• To determine the effectiveness of corrective and preventive actions taken
• Watching accidents and learning lessons

 
 
 
 
 
 

Terms Of The Vigilance System 

    Report immediately upon learning of the events

• Any device failure, damage that may lead to serious injury or death
• Security-based systematic recall

 
 
 
 
 
 

Principles Of The Vigilance System 

• Authorized institutions share information among themselves
• The report should not be interpreted as an admission of error.
• Not every report may require corrective action.
• Incident reporting must be reported to all concerned
• If two separate devices caused the incident, both manufacturers must report.
• It is recommended that the approved institution be informed.  

 
 
 
 
 
 

Decision Making Reporting 

• event (or possible event) type
• manufacturer's device?
• Was the incident caused by the device or the lack of information provided with the device?

• Death of a user, patient, or other person
• Severe injury to user, patient or other person

 
 
 
 
 
 

Types Of Events That Can Be Reported 

    POSSIBLE EVENTS 

• deterioration/deficiency in performance characteristics
• a device that can cause an event, although there is no deterioration in its performance
• lack of user manual and information on the product

 
 
 
 
 
 

Relationship Between Device And Event 

When evaluating the relationship between device-event or approximate event 

• opinions of medical staff,
• the manufacturer's assessment,
• previous similar events,
• other evidence in the hands of the manufacturer 

Are taken into consideration 
 

 
 
 
 
 
 

Report Notification Period  

• Events: 10 days

 

• Possible events: 30 days

 

• Recall and

Advisory Warnings: Immediately after users are informed  
 

The notification period is the time until the manufacturer is first aware of the incident and the Competent Authority receives the report.

 
 
 
 
 
 

Death or serious injury

that have occurred is it? 

Occurrence

is it possible? 

Report

it's not necessary 

The device was not the cause of the incident

Can it be proved within 10 days? 

The device was not the cause of the incident

Can it be proved within 30 days?  

Is the event within the EU

has it occurred? 

Is the event within the EU

has it occurred? 

Device CE mark

does he carry it?  

Device CE mark

does he carry it? 

With similar products bearing CE mark

problems studies

does it detect? 

Report

it's not necessary 

Report

it's not necessary 

Report

it's not necessary 
 

Reporting should be done

(in the shortest possible time) 

Probable Event

(Within 30 days

reporting must be done!) 

       Event

(Within 10 days

reporting must be done!) 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

No 

No 

No 

No 

Yes 

No 

No 

No 

No 

No 

Yes 

Vigilance System

 
 
 
 
 
 

Reporting Location 

• Authorized agency of the country where the incident occurred
• Outside the EU

• Authorized body of the country in which the approved Organization for Class II and III devices is located
• Authorized institution in the country where the manufacturer is located for Class I devices

 
 
 
 
 
 

Initial Report Content 

• Manufacturer information
• The manufacturer of the date of being notified of the incident
• Device information
• Approved Organization Identification No.
• Details of the incident
• The place where the device is located

 
 

• Point of contact
• Manufacturer's pre-views
• Other authorized institutions where reporting is carried out
• Other EU countries where the device is on sale

 
 
 
 
 
 

Activities After The First Report 

    MANUFACTURER

• Should do a review on the event
• Report to the Competent Authority
• Develop corrective actions in cooperation with the Competent Authority
• As a result of the reviews, it must prepare a final report and submit it to the Competent Authority

 
 

    AUTHORIZED INSTITUTION

• it must inform the sending party that the report has been received
• should record the report, categorize this event
• evaluate the report
• monitor the manufacturer's research
• contact other authorities

 
 
 
 
 
 

Final Report 

• Declaration of all activities and results shown during the research
• The Competent Authority should put the manufacturer's final report on file and carry out any other necessary investigations.
• The final report should also be reported to other authorized institutions that have been notified of the first report.
• The file is closed.

 
 
 
 
 
 

Manufacturer's requirements for market surveillance 
 

THE MARKET MONITORING SYSTEM REQUIRES THE MANUFACTURER TO: 

• Overview of acquired experience with devices in the country,

 

• Investigating elements such as corrective action practices, the structure of the medical device and the ratio of existing risks,

 

• Informing the authorized representative about negative events and possible negative events.

 
 
 
 
 
 

Feedback sources for manufacturer's warning system 

For the SURVEILLANCE SYSTEM FEEDBACK:

• Expert user groups,
• Customer reviews,
• Customer complaints and warranty claims-requests,
• Service and repair information,
• Literature reviews,
• Complaints reported by users other than,
• Device series and registry entries
• User reactions can be used during the training program.

 

    In many cases, the manufacturer's surveillance system is part of the internal quality system. Although a certified quality system is not mandatory for manufacturers of Class 1 non-sterile and non-measuring medical devices, post-market surveillance is a necessity. 

 
 
 
 
 
 
 

 

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GENERAL DIRECTORATE OF TREATMENT SERVICES

DEPARTMENT OF BIOMEDICAL ENGINEERING SERVICES 

COMPLIANCE WITH EU TECHNICAL LEGISLATION AND

NATIONAL PROGRAM

WITHIN

"MEDICAL DEVICES LEGISLATION’

 
 

        FREE
MOVEMENT OF GOODS 

• Cosmetics
• Drugs and Psychotropic Substances
• Medical Devices
• Active Medical Devices That Can Be Placed In The Body
• Medical Diagnostic Devices Used Outside The Body (In Vitro)
• Toys
• Eatables
• Detergents

 
 

LEGAL BASIS 

• “Basis of Medical Device Regulations, Law No. 4703 " on the preparation and implementation of technical legislation on products”

 

- “Basic Law on health services " No. 3359 is “Decree Law on the organization and duties of the Ministry of Health”No. 181. 

 
 

CONTRIBUTIONS OF THE LEGISLATION 

• The Legal Gap Has Been Filled.
• Consumer Rights Were Protected By Making The Manufacturer Directly Responsible.
• The ministry will carry out market surveillance and supervision of products released in the health sector.
• The devices will undergo various testing and certification stages.
• The ministry will appoint Notified Bodies and oversee testing and certification Laboratories.

 
 

WHAT DOES REGULATION BRING? 

    In order for devices that fall within the scope of the regulation (except for bespoke and clinical research devices) to be included in the market, they are required to bear the CE mark.

   

    Accordingly, as of the effective date of the Regulation (31 December 2003) medical devices are defined as all devices (except for clinical research purposes, with bespoke manufactured appliances) on the market conformity assessment process before being placed through the patient, the practitioner, and must carry the CE mark which means a safe product to third parties. 
 

 
 

               
 

"CE MARKING” 

                                                             

 
 

    CE ;

    It is a sign of conformity with the new approach directives of the European Union, showing that the product attached to it is safe for HUMAN, ANIMAL and ENVIRONMENT.

 
 

CE; letters in French,  

"EUROPENNE CONFORMITE”

expressed as and compliance with Europe,

marking and evaluation system

description

 
 

"CE Mark”  

    It serves as a kind of passport so that products can be released into free circulation in EU member states. 

    It is not a quality brand or product brand by itself. Therefore, TSE cannot be used instead of brands such as TÜV.

 
 

    The European Union began the implementation of the CE mark in 1985. 

    In Turkey, 11.01.2002 date and 24643 entered into force with the Official Gazette, 14.02.2004 date and 25373 began to be published in the Official Gazette.

 
 

    The CE conformity mark must be at least 5 mm high in size.  

    The CE Mark must be placed on the product, and in cases where this is not possible, on its packaging. 

 
 

    As part of the new approach directives and policy of the European Union, there are 24 directives that require the CE mark so far, and the main product groups are;

• Toys
• Construction Materials
• Low Voltage Devices
• Machines
• Medical Devices
• Freezers
• Telecommunication Devices

 
 

NOTIFIED BODY 

    Notified Body, 

    From among the test inspection and/or certification bodies, to participate in conformity assessment activities within the framework of Medical Device Regulations,  

    In the "Law on Preparation and Implementation of Technical Legislation on Products" dated 29.06.2001 and numbered 4703, regulations and  

 It is a public or private organization authorized within the framework of the "Regulation on Conformity Assessment Bodies and Notified Bodies" published in the Official Gazette dated 17.01.2002 and numbered 24643 and in the framework of the criteria set out by the General Directorate of Treatment Services. 

 
 

    Internet address of Notified Bodies operating in the field of Medical Devices in the European Union; 
 

    http://europa.eu.int/comm/enterprise/newapproach/legislation/nb/notified_bodies.htm 

NOTIFIED BODY

 
 

MEDICAL DEVICE REGULATION 93/42/EEC

 
 

• Directive 90/385 / EEC:
  Active Implantable Medical Devices

 

• Directive 93/42/EEC:
  Medical Devices

 

• Directive 98/79/EC:
   Medical Diagnostic Devices Used Outside the Body (In Vitro Diagnostic Medical Devices)

 

THREE BASIC DIRECTIVES ON MEDICAL DEVICES

 
 

ACTIVE MEDICAL DEVICE THAT CAN BE PLACED ON THE BODY 

Devices that are supposed to be permanently placed in the human body and are a power source for it to perform its function. 

Examples:

• Pacemakers,
• Diffusion pumps used in oncological applications,

 
 

MEDICAL DIAGNOSTIC DEVICES USED OUTSIDE THE BODY 

• Reagent (Myar - separator) or reagent product,
• Calibrator, control material, kit,
• Device, apparatus, equipment or system,

and samples taken from the human body,

• A psychological or pathological condition,
• An inherited abnormality
• Safety and compliance with potential buyers,
• Treatment measures

These are the devices intended to be used outside the human body in order to obtain information about it.

 
 

MEDICAL DIAGNOSTIC DEVICES USED OUTSIDE THE BODY 

  Examples:

• Reagents used in pregnancy testing,
• Reagents used to determine blood type,
• Reagents used in AIDS diagnosis,
• Sample containers used for transporting and preserving human body samples

 
 

Does not provide its primary function when used in humans with pharmacological, chemical, immunological or metabolic effects;

but can be supported by these effects while performing its function,
- diagnosis, prevention, monitoring, treatment
or alleviation of a disease in humans;
 - diagnosis, monitoring, treatment,
 mitigation or relief of an injury or grievance;
- research, alteration or substitution of an anatomical or
physiological function;
contraception;
 is any tool, device, tool, material or other material produced for the purpose, that can be used alone or in combination, and also used with computer software if necessary to fulfill its intended function. 

MEDICAL DEVICE

 
 

Examples:

• Anastesis equipment, MRI equipment, sterilizer, surgery equipment, etc. hospital equipment,
•   Dental hand tools, dental implants and materials (including amalgam and porcelain), hardeners,
• Measurement and diagnostic devices, glasses and lenses used in surveillance,
• Ear prosthesis, hearing aid, etc. audio metric devices,
• Artificial muscle, hip implant, walking support, corset etc. implant or non-implant prostheses,
• Disabled vehicles such as wheelchairs and rehabilitation equipment,
• Disposable items such as latex gloves, surgical drapes, tampons.

 

MEDICAL DEVICE

 
 

OUT OF SCOPE PRODUCTS 

• Products covered by 65/65/EEC and 89/381/EEC,
• Cosmetics covered by 76/768/EEC,
• Human blood, blood products, plasma and blood cells,
• Human or animal origin transplant, tissue or cells,
• Personal protective equipment covered by 89/686/EEC

 

MEDICAL DEVICE

 
 

ANNEX 1: BASIC REQUIREMENTS

- General Requests:

• High level of health and safety protection,
• Production in accordance with safety principles, at the level of technology,
• Ensuring projected performance,
• Clinical environment and safety of patients are not adversely affected,
• Avoid adverse effects of prescribed use during transport and storage,
• Acceptable level of risks associated with unwanted side effects

- Other Requests:

• Chemical, physical and biological properties,
• Infection and microbial transmission,
• Production and environmental features,
• Devices with measurement function,
• Protection against radiation,
• Devices that are connected to an energy source or that are its own energy source,
• Information provided by the manufacturer

 

MEDICAL DEVICE

 
 

SPECIAL PURPOSE DEVICES 

• Devices to be used for clinical research purposes

  (Article 15 and Annex VIII) 

• Customer specific order devices

  (Article 11 and Annex VIII)  
 

CE MARKING WILL NOT BE PERFORMED ON THESE DEVICES ! 

MEDICAL DEVICE

 
 

Devices according to medical devices directive 93/42/EEC, 

Class I (Low Risk),

Class IIa (Medium Risk),

Class IIB (Medium Risk),

Class III (High Risk) 

it is divided into 4 main classes.  
 

The directive explains how to classify products. 

CLASSIFICATION OF MEDICAL DEVICES

 
 

2 BASIC CRITERIA USED IN CLASSIFICATION: 

I. Occupancy

Temporary use (less than 60 Minutes)

Short-term use (less than 30 days)

Long-term use (longer than 30 days) 

II. Invasive Status

Invasive device : a device inserted into the body through a body opening or from the body surface,

Surgical invasive device : invasive device inserted into the body by surgical intervention,

Implant device: a device that is surgically inserted into the human body and is intended to be permanent (at least 30 days). 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES 

I. Rules for Non-invasive devices (rule 1-4) 

Rule 1: all non-invasive devices are Class I (with exceptions). 

Rule 2: non-invasive devices used to receive, give or store blood, body fluids or tissues, and to release liquids or gases into the body are Class IIA. 

Rule 3: all non-invasive devices used to regulate the biological and chemical compositions of blood, body fluids, or other liquids to be distributed to the body are Class IIB.

If these devices are used for filtration, centrifuge or gas exchange purposes, they are Class IIA. 

Rule 4: all non-invasive devices in contact with injured skin,

               - If used for compression or absorption of leaks, Class I

               - But if it is to be used in the process of wounds that will heal with a procedure, Class IIB

               - In other cases, Class IIa 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES

II. Rules About Invasive Devices (Rule 5-8) 

Rule 5: from devices compatible with body orifices that are not surgical invasive devices and are not combined with other active devices,

• Devices for Temporary Use Class I,
• Devices for short-term use class IIa. (However, Class I is used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum)
• Devices for long-term use Class IIB. (However, Class IIA is used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum, which is not suitable for absorption from the mucous membranes and is used in the oral cavity up to the pharynx)
• Class IIa, all invasive devices compatible with body entrances intended for use in conjunction with an active medical device class IIa or higher, other than surgical invasive devices.

 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 6: all surgical invasive devices prescribed for temporary use are Class IIA. 

- Devices that basically diagnose, monitor and correct a disorder in the heart or central circulatory system by directly contacting these parts of the body are Class III.

- Reusable surgical devices Class I.

- Devices that provide energy in the form of ionizing radiation Class IIB. 

- Devices with biological effect, all or most of which are absorbed Class IIB.

- If, these invasive devices give medication through a release mechanism

convenient and Hazardous Devices Class IIB. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 7: all surgical procedures prescribed for short-term use are invasive, except in the following cases

the devices are Class IIA.

- Devices that basically diagnose, monitor and correct a disorder in the heart or central circulatory system by directly contacting these parts of the body are Class III.

- Devices used especially by direct contact with the central nervous system Class III.

- Devices that provide energy in the form of ionizing radiation Class IIB.

- Devices with biological effect, all or most of which are absorbed Class III.

- Devices that undergo chemical changes in the body or are used to deliver drugs, except those that are inserted into the tooth. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 8: Except for the following situations, all implant devices and surgical invasive devices that are expected to be used for a long time are Class IIb.  

- Devices that are placed on teeth and whose retention is ensured by teeth and / or gum tissue Class IIa.

- Direct contact with the heart, Central circulatory system or central nervous system

devices used are Class III.

- Devices with biological effects or absorbed in all or most of them are Class III.

- Devices that undergo chemical changes in the body or used for drug delivery, except those placed in teeth, are Class III.  

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES 

III. Additional Rules Regarding Active Medical Devices (Rule 9-12) 

Rule 9: All active therapeutic devices for energizing or providing energy conversion are Class IIa. However, considering its structure, density and energy application location, those who pose a potential risk in the human body in giving and receiving energy or providing energy conversion fall into Class IIb.

Devices that monitor and control the performance of active therapeutic devices in Class IIb or active medical devices intended to directly affect the performance of these devices are also Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 10: The following diagnostic active devices fall into Class IIa:

- Devices that provide energy to be absorbed by the human body, except devices used to illuminate the patient's body in a visible spectrum,

- Devices used to display the distribution of radiopharmaceuticals in living tissues,

- Devices that allow direct diagnosis or monitoring of vital physiological functions.

However, those aiming to monitor changes that may cause immediate danger in the patient's condition such as central nervous system activities, changes in respiratory and heart functions are included in Class IIb.

Devices that emit ionizing radiation and devices for interventional radiological diagnosis and treatment and active devices for controlling and monitoring these devices or directly affecting their performance fall into Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 11: All active devices that deliver or take drugs, bodily fluids, and other substances into the body fall into Class IIA. However, considering the method of administration, the relevant part of the body and the nature of the substances administered, if this procedure poses a potential risk, they are in Class IIb. 

Rule 12: All other active devices are in Class I. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

CLASSIFICATION RULES

IV. Additional Rules On Active Medical Devices (Rule 13-18) 

Rule 13: When used separately, all devices that are considered as a medical product and contain a substance that has an activity supporting the effect of the device on human beings as an internal part fall into Class III.

All devices that contain human blood derivative as part of a whole fall into Class III. 

Rule 14: All devices used to prevent the transmission of birth control or sexually transmitted diseases fall into Class IIb. But if it is an implant or an invasive device that is prescribed for long-term use, they fall into Class III. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Rule 15: To disinfect contact lenses, to clean, rinse and moisturize as needed

devices that serve enter Class IIB.

Devices that specifically serve to disinfect medical devices fall into Class IIA.

This rule does not apply to other products that clean medical devices other than contact lenses with physical effect. 

Rule 16: Inactive devices used especially for the purpose of recording X-ray diagnostic images fall into Class IIa. 

Rule 17: Animal tissue or dead tissue, excluding devices intended for contact with healthy skin only

all devices manufactured using their parts fall into Class III. 

Rule 18: Unlike other rules, blood bags fall into Class IIb. 

MEDICAL DEVICE CLASSIFICATION RULES

 
 

Annex VII

Technical File 

Vigilance System 

Class-I Device

(non-sterile / non-measuring function) 

Declaration of conformity & CE mark 

CONFORMITY ASSESSMENT PROCESS FOR CLASS-I PRODUCTS 

The manufacturer will monitor Annex VII and prepare a Technical File.

 
 

Class I Device

(sterile / measuring function) 

Annex VII

Technical File 

Vigilance System 
 

Declaration of conformity & CE mark 

Annex V*

EN ISO 13485

(EN 46002) 

Annex VI*

EN 46003 

Annex IV*

Unit Validation 

* sterile / measuring function considerations

 
 

Manufacturer will prepare technical file according to Annex VII

                                                           +

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

or, 

(iii) EC Declaration of conformity in accordance with Annex VI (Product Quality Assurance System) (module D) 
 

Note: instead of all these, the manufacturer may have a full Quality Assurance System according to Annex II. (MODULE H) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS IIa PRODUCTS

 
 

Class IIA Device 

Annex VII

Technical File 
 
 

Declaration of conformity & CE mark 

Appendix V

Vigilance System

EN ISO 13488

(EN 46002) 

Annex VI

Vigilance system en 46003 

Annex II

Technical File

Vigilance System

EN ISO 13485

(EN 46001) 

EkIV

Vigilance System

Unit Validation

 
 

They will do the manufacturer: 

a) complete Quality Assurance System according to Annex II (module H)

(Annex II, Article 4 does not apply in this case – approval of the technical file to the Notified Body -) 

or, 

b) EC type Examination according to Annex III (Module B) 

                                                           +

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

or, 

(iii) EC Declaration of conformity in accordance with Annex VI (Product Quality Assurance System) (module D) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS IIb PRODUCTS

 
 

Class II B device 

Annex III

Type Review 
 
 

Declaration of conformity & CE mark 
 

Appendix V 

Vigilance System

EN ISO 13488

(EN 46002) 

Annex VI

Vigilance System

EN 46003 

Annex II

Technical File

Vigilance System

EN ISO 13485

(EN 46001) 

Annex IV

Vigilance System

Unit Validation

 
 

The manufacturer will: 

a) complete Quality Assurance System according to Annex II (module B)

(Annex II, Article 4 applies in this case – the design file is approved by the Notified Body -) 

or, 

b) EC type Examination according to Annex III (module H) 

                                                           + 

(i) EC verification according to Annex IV (Module F) 

or, 

(ii) EC Declaration of conformity in accordance with Annex V (Production Quality Assurance System) (module E) 

CONFORMITY ASSESSMENT PROCESS FOR CLASS III PRODUCTS

 
 

Class III Device 

Annex III

Type Review 
 

Declaration of conformity & CE mark 

Appendix V

Vigilance system EN ISO 13488

(EN 46002) 

Annex II 

Vigilance System

EN ISO 13485

(EN 46001) 

Annex II.4 

Review The Design File 
 
 

Annex IV

Vigilance System

Unit Validation

 
 

MEDICAL DEVICE CONFORMITY ASSESSMENT MODULES 

Annex I-Basic Requirements 

Annex II - EC Declaration Of Conformity (complete Quality Assurance System) (module B)

                   Detailed design documents of the product,

                   Risk analysis,

                   Quality plans,

                   Clinical data and user's guide (Annex X),      

                   etc.a technical document package (Technical File) consisting of is approved by an approved organization.  

Annex III-EC type Examination (module H)

                     Type approval is made by an approved organization. 

Annex IV - EC Verification (Module F)

                    Statistical control of each product or samples to be taken from cafes by an approved organization (applies to products with Type Approval) 

Annex V-AT Declaration Of Conformity (Production Quality Assurance System) (module E) 

Annex VI - EC Declaration Of Conformity (Product Quality Assurance System) (Module D) 

Annex VII-EC Declaration Of Conformity (module A)

                     The Technical File is prepared.                  

 
 

BASIC STANDARDS USED IN PRACTICE 

• General Standards

  - Safety For Medical Devices (Guide 513)

   - Quality Management System (ISO 9000: 2000)

   - Quality Management System specific to medical devices (ISO 13485 :2003) 

• Process Standards

  - Risk management (ISO 14971: 2000)

   - Clinical Research (ISO 14155)   

 
 

•   Electromagnetic Compatibility

  - IEC 601-1-2 

• Bio Compatibility

  - ISO 10993 

• Functional Safety

  - Product group specific standards 

• Labeling and symbols

  - EN 980: 1994-terminology, symbols and information

  - EN 1041: 1995-Information provided by the manufacturer 

• Sterility

  - En 550 (specific standards based on sterilization methods) 

BASIC STANDARDS USED IN PRACTICE

 
 

Annex 2 

EC declaration of conformity 

MDD 

Annex II 

Full Quality Assurance System 

BS EN ISO 9001 plus BS EN 46001 

Annex III 

EC Type-Examination 

Annex IV 

Annex V 

Annex VI 

Annex VII 

Production Quality Assurance 

Product Quality Assurance 

EC Verification 

BS EN 9002 plus BS EN 46002 

BS EN 9003 

Annex 3 

Annex 4 

Annex 5 

Full Quality Assurance System 

EC Type Examination 

EC Verification 

Production Quality Assurance 

BS EN ISO 9001 plus BS EN 46001 

BS EN ISO 9002 plus BS EN 46002 

AIMD 

MDD Annex 

Title 

Applicable EN Standard 

MDD and AIMD annexes

 
 

CERTIFICATE TYPES 

he 

he 

he 

he 

he 

he 

Definition of change21:

• Published (issued)
• Adapted (modified)
• Have been Red (refused)
• Cancelled(withdraw)
• Extended time)
• Refurbished (renewal)

 

+

+

he

he 

+

+

he

he 

+

+

he

he 

+

+

he

he 

+

+

he

he 

+

+

he

he 

Notified Body (NB):

• Authorized signature
• EC approval number ……
• Name and address
• Tel / Fax-No.

 

he 

he 

he 

he 

he 

he 

Special conditions of validity, if any 

+ 

+ 

- 

+ 

- 

- 

Scope of quality system20 

+

he

o19

- 

+

he

o19

- 

+

he

+

+ 

+

he

o19

- 

+

he

+

- 

+

he

+

- 

About device17:

• Product category names18

Terminology Code18

• Name / description of model / type
• Serial or batch number

 

he

he 

he

he 

he

he 

he

he 

he

he 

he

he 

Representatives16:

• Name
• Address

 

+

+ 

+

+ 

+

+ 

+

+ 

+

+ 

+

+ 

Manufacturing:

• Name
• Address

 

+ 

+ 

+ 

+ 

+ 

+ 

NB file number reference15 

he

+ 

he

+ 

he

+ 

he

+ 

he

+ 

he

+ 

Main text:

• National regulations references13
• Text14

 

+ 

+ 

+ 

+ 

+ 

+ 

Name12 

he 

he 

he 

+ 

+ 

+ 

Expiration date11 

+ 

+ 

+ 

+ 

+ 

+ 

Date of issue 10 

+ 

+ 

+ 

+ 

+ 

+ 

Certificate number9 

VI6, 7 

V /

55,7,8 

IV /

44,7 

II, 3 /

2, 33 

III /

32 

II, 4 /

2, 41 

Certificate Type

Content

 
 

FOOTNOTES: 

• Single within ⁹ organizations
• ¹⁰ no format is provided for how the data will be presented in the certificate. "Unless there is a specified case in the contract, the validity of the certificate starts from the date of issue." A format will then be stipulated for entries into the EUDAMED (European Data Exchange for Medical Devices) database.
• ¹¹ See: date of publication;last Limited. Recommendation for text: "this certificate is valid for x years from the date of publication.” Maximum 5 years for Annex II and III ( comment / recommendation: requested and required for all certificates)
• ¹² required for identification of Certificate types (e.g. conformity measurement procedure published in certificates covered by the directive where supported by the directives )
• ¹³ use the text “ " MDD ... as presented in national legislation.”

 
 

FOOTNOTES: 

• ¹⁶ if possible, for example, it can be an authorized representative or a responsible representative .
• ¹⁷ either A) or b); c) subject to annex IV.
• ¹⁸ umdns naming if possible
• ¹⁹ one of the following alternatives must be obtained: a) model numbers directly in the certificate or attached to the certificate; b) model list in the files of the approved organization with a link through the NB file reference; all declarations of conformity in the hands of the approved organization. Objective: to clearly show that the product is covered by the NB approval of the relevant certificate.
• ²⁰ regarding the scope of the quality system; for example, the tools or activities covered

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC TYPE EXAMINATION CERTIFICATE

(Directive 93/42/EEC on medical devices Annex III)we declare that directive 93/42/EEC on medical devices to which the signatory below is connected has been examined by a pattern on the device (s) listed below in accordance with the requirements of the national legislation introduced in annex III. We acknowledge that the device(s)listed below comply with the relevant provisions of the directive mentioned above.  

III / 3  

EC DESIGN-EXAMINATION CERTIFICATE

(Medical devices directive 93/42/EEC Annex II Section 4)we declare that the undersigned person that is connected to the medical devices directive 93/42/EEC Annex II Section 4. listed below are according to the requirements of the national legislation which was presented in that the device(s) reviewed on pattern review. We confirm that the device(s)listed below comply with the provisions of Directive 93/42/EEC annex II section 4, which are introduced in the national legislation on medical devices.  

II, 4/2, 4

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC VERIFICATION CERTIFICATE

(Directive 93/42/EEC on medical devices Annex IV)we declare that an EC verification has been made on the series or batches of devices listed below in accordance with the requirements of the national legislation introduced in Directive 93/42/EEC on medical devices to which the signatory below is connected. We acknowledge that the device(s)listed below comply with the relevant provisions of the directive mentioned above.  

IV / 4  

EC CERTIFICATE FULL QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC on medical devices Annex II)we declare that the full quality assurance system referred to below has been examined in accordance with the requirements of the national legislation presented in Directive 93/42/EEC on medical devices to which the signatory below is connected, Annex II (except Section 4). We confirm that this complete quality assurance system complies with the relevant provisions of the directive.  

II, 3/2, 3

 
 

Examples of text related to different certificates under MDD/AIMD  
 

EC CERTIFICATEPRODUCT QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC Annex VI on medical devices)we declare that the product quality system mentioned below has been reviewed in accordance with the requirements of the national legislation introduced in Annex VI of Directive 93/42/EEC on medical devices to which the signatory below is affiliated.  We confirm that this product quality system complies with the relevant provisions of the directive.  

VI  

EC CERTIFICATEPRODUCTION QUALITY ASSURANCE SYSTEM APPROVAL CERTIFICATE

(Directive 93/42/EEC on medical devices Annex V)we declare that directive 93/42/EEC on medical devices to which the signatory below is connected has been reviewed in accordance with the requirements of the national legislation introduced in Annex V.  We confirm that this product quality system complies with the relevant provisions of the directive. 

V / 5

 
 

Declaration Of Conformity(1) 

• The manufacturer must issue a written declaration of Conformity before attaching the CE mark to the product.

 

• This declaration must cover a certain number of manufactured products and must be kept by the manufacturer.

 

• Where Annex IV referred to for conformity assessment is used, the group or serial number of the device must be defined.

 
 

Declaration Of Conformity (2) 

Content

• Name Of The Document ("Declaration Of Conformity”)
• Manufacturer name and address
• Name and Address of Authorized Representative
• Generic Name Of The Device
• Description Of The Device
• Attachments used to ensure compliance with the directive
• Reference to authorized institution document(applicable case)
• Identification of authorized institution (applicable case)
• Signature Of The Authorized Person

 
 
 
 

59  

Technical Documentation and Design File

 
 
 
 
 
 

The purpose of technical documentation is to demonstrate compliance with the requirements of the directives.

•   requirements Annex II.3 and Annex III.It was defined in 3 te.Appendix V.3 and Annex VII of MDD.3

 

•   Design files are requested for Class III products. if Annex II is selected for the compliance report process (Annex II.4, MDD).

 

Technical Documentation and Design File

 
 
 
 
 
 

•   General product description including Planned variations
•   Design drawings and calculations,design specifications, definitions, diagrams of parts, accessories, etc.b.

 

•   Techniques used to control and approve design (Annex II).

 

•   If harmonized standards are not used, definitions of solutions used to adapt the necessary basic requirements

 

Prove that the device meets the basic requirements when used with other devices 

Contents (1)

 
 
 
 
 
 

• Definition of sterilization method, approval of sterilization

 

• Data on drug ingredients used in the device
• Information about production methods
• Definition of quality assurance and inspection techniques
• Risk Analysis

 

• Clinical Data

 

Contents (2)

 
 
 
 
 
 

•   Test results and used test equipment(design confirmation & validity)

 

• Labels and instructions for use

 
 

Contents (3)

 
 
 
 
 
 
 

1 Purpose, Target, Revision history

2 Device descriptions and variants

       (Including functional identification, performance, intended use)

3 Design Documentation and design control procedures

• demonstration of compliance with basic requirements
• Case related to annex I of Article 7.4 (Medical Products)

6 identification of Production Process, Quality Assurance

7 Material and parts testing (eg. Packaging)

8 specific product testing (eg. Safety, Sterility, Biocompatibility)

9 User information (instructions, labels, service manuals)

10 Risk Analysis

11 Clinical Data       

Being

 
 
 
 

65  

• Technical documentation should cover all products and be put together for a family of products.

 

• Technical documentation must be updated when changing the product or applicable process or applicable requirements. (ex. Standards, guidelines)

 

•   The approved institution should be informed of significant changes in the quality system or changes in products.

 

Technical Documentation-Requirements (1)

 
 
 
 

66  

• If Annex II is selected in the compliance report activity, only design files are required for class III devices.

 

• Implementation of testing of design files must be by invitation of the approved organization.The application should define design, production and performance

 

• In addition, the application must include the documents specified in Article 3.2 c of Annex II.

 

Design Files (1)

 
 
 
 
 
 

• After a successful design file has been tested, the Design File Certificate will be issued by the Notified Body.

 

• Associated with the MDD design file certificate (Annex II.4, MDD) Annex II.A certificate according to 3 is required to hit the CE mark on the class III product.

 

• Design file changes must be approved by the approved institution.

 
 

Design File (2)

 
 
 
 
 
 

Vigilance System 

 
 
 
 
 
 

Vigilance System 

• Applied in all CE marking Directives for Medical Devices

• AIMDD, MDD, IVDD

It is a system of reporting and evaluating negative events.
(Vigilance Reporting Procedure, Requirement Procedure)

 
 
 
 
 
 

Purpose Of The Vigilance System 

• Protecting community health and safety
• Preventing accidents from happening again by evaluating
• To determine the effectiveness of corrective and preventive actions taken
• Watching accidents and learning lessons

 
 
 
 
 
 

Terms Of The Vigilance System 

    Report immediately upon learning of the events

• Any device failure, damage that may lead to serious injury or death
• Security-based systematic recall

 
 
 
 
 
 

Principles Of The Vigilance System 

• Authorized institutions share information among themselves
• The report should not be interpreted as an admission of error.
• Not every report may require corrective action.
• Incident reporting must be reported to all concerned
• If two separate devices caused the incident, both manufacturers must report.
• It is recommended that the approved institution be informed.  

 
 
 
 
 
 

Decision Making Reporting 

• event (or possible event) type
• manufacturer's device?
• Was the incident caused by the device or the lack of information provided with the device?

• Death of a user, patient, or other person
• Severe injury to user, patient or other person

 
 
 
 
 
 

Types Of Events That Can Be Reported 

    POSSIBLE EVENTS 

• deterioration/deficiency in performance characteristics
• a device that can cause an event, although there is no deterioration in its performance
• lack of user manual and information on the product

 
 
 
 
 
 

Relationship Between Device And Event 

When evaluating the relationship between device-event or approximate event 

• opinions of medical staff,
• the manufacturer's assessment,
• previous similar events,
• other evidence in the hands of the manufacturer 

Are taken into consideration 
 

 
 
 
 
 
 

Report Notification Period  

• Events: 10 days

 

• Possible events: 30 days

 

• Recall and

Advisory Warnings: Immediately after users are informed  
 

The notification period is the time until the manufacturer is first aware of the incident and the Competent Authority receives the report.

 
 
 
 
 
 

Death or serious injury

that have occurred is it? 

Occurrence

is it possible? 

Report

it's not necessary 

The device was not the cause of the incident

Can it be proved within 10 days? 

The device was not the cause of the incident

Can it be proved within 30 days?  

Is the event within the EU

has it occurred? 

Is the event within the EU

has it occurred? 

Device CE mark

does he carry it?  

Device CE mark

does he carry it? 

With similar products bearing CE mark

problems studies

does it detect? 

Report

it's not necessary 

Report

it's not necessary 

Report

it's not necessary 
 

Reporting should be done

(in the shortest possible time) 

Probable Event

(Within 30 days

reporting must be done!) 

       Event

(Within 10 days

reporting must be done!) 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

No 

No 

No 

No 

Yes 

No 

No 

No 

No 

No 

Yes 

Vigilance System

 
 
 
 
 
 

Reporting Location 

• Authorized agency of the country where the incident occurred
• Outside the EU

• Authorized body of the country in which the approved Organization for Class II and III devices is located
• Authorized institution in the country where the manufacturer is located for Class I devices

 
 
 
 
 
 

Initial Report Content 

• Manufacturer information
• The manufacturer of the date of being notified of the incident
• Device information
• Approved Organization Identification No.
• Details of the incident
• The place where the device is located

 
 

• Point of contact
• Manufacturer's pre-views
• Other authorized institutions where reporting is carried out
• Other EU countries where the device is on sale

 
 
 
 
 
 

Activities After The First Report 

    MANUFACTURER

• Should do a review on the event
• Report to the Competent Authority
• Develop corrective actions in cooperation with the Competent Authority
• As a result of the reviews, it must prepare a final report and submit it to the Competent Authority

 
 

    AUTHORIZED INSTITUTION

• it must inform the sending party that the report has been received
• should record the report, categorize this event
• evaluate the report
• monitor the manufacturer's research
• contact other authorities

 
 
 
 
 
 

Final Report 

• Declaration of all activities and results shown during the research
• The Competent Authority should put the manufacturer's final report on file and carry out any other necessary investigations.
• The final report should also be reported to other authorized institutions that have been notified of the first report.
• The file is closed.

 
 
 
 
 
 

Manufacturer's requirements for market surveillance 
 

THE MARKET MONITORING SYSTEM REQUIRES THE MANUFACTURER TO: 

• Overview of acquired experience with devices in the country,

 

• Investigating elements such as corrective action practices, the structure of the medical device and the ratio of existing risks,

 

• Informing the authorized representative about negative events and possible negative events.

 
 
 
 
 
 

Feedback sources for manufacturer's warning system 

For the SURVEILLANCE SYSTEM FEEDBACK:

• Expert user groups,
• Customer reviews,
• Customer complaints and warranty claims-requests,
• Service and repair information,
• Literature reviews,
• Complaints reported by users other than,
• Device series and registry entries
• User reactions can be used during the training program.

 

    In many cases, the manufacturer's surveillance system is part of the internal quality system. Although a certified quality system is not mandatory for manufacturers of Class 1 non-sterile and non-measuring medical devices, post-market surveillance is a necessity.