Guidance MEDDEVs

The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.

Disclaimer : Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated in all MEDDEVs. The necessary revision is under way.

 

TITLE

2.1
Scope, field of application, definition

MEDDEV 2.1/1pdf(19 KB)  Definitions of "medical devices", "accessory" and "manufacturer"  
April 1994

 

MEDDEV 2.1/2 rev.2pdf(14 KB)  Field of application of directive "active implantable medical devices"
April 1994

 

MEDDEV 2.1/2.1pdf(12 KB) Field of application of directive "active implantable medical devices"
February 1998

 

MEDDEV 2.1/3 rev.3pdf(182 KB)  Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative
December 2009

 

MEDDEV 2.1/4pdf(21 KB) Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective  equipment
March 1994
For the relation between the MDD and directive 89/686/EEC concerning personal protective
equipment, please see the Commission services interpretative document of 21 August 2009pdf(32 KB)

 

MEDDEV 2.1/5pdf(10 KB) Medical devices with a measuring function
June 1998

 

MEDDEV 2.1/6pdf(323 KB) Qualification and Classification of stand alone software
January 2012  

 

2.2
Essential requirements

 

MEDDEV 2.2/1 rev.1pdf(16 KB) EMC requirements
February 1998

 

MEDDEV 2.2/3 rev.3pdf(17 KB)"Use by" - date
June 1998

 

MEDDEV 2.2/4pdf(39 KB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
January 2012 

2.4
Classification of MD

MEDDEV 2.4/1 rev.9pdf(654 KB) Classification of medical devices                                                                             
June 2010

2.5
Conformity assessment procedure

General rules

 

Quality assurance.
Regulatory auditing of quality systems of medical device manufacturers
(See document in the GHTF-Global Harmonization Task Force)

 

MEDDEV 2.5/3 rev.2pdf(9 KB) Subcontracting quality systems related
June 1998

 

MEDDEV 2.5/5 rev.3pdf(7 KB) Translation procedure
February 1998

 

MEDDEV 2.5/6 rev.1pdf(10 KB) Homogenous batches (verification of manufacturers' products)
February 1998

 

Conformity assessment for particular groups of products

 

MEDDEV 2.5/7 rev.1pdf(93 KB) Conformity assessment of breast implants
July 1998

 

MEDDEV 2.5/9 rev.1pdf(97 KB) Evaluation of medical devices incorporating products containing natural rubber latex
February 2004

 

MEDDEV 2.5/10 pdf(78 KB) Guideline for Authorised Representatives
January 2012  

 

2.7
Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev.3pdf(378 KB) Clinical evaluation: Guide for manufacturers and notified bodies
December 2009
Appendix 1: Clinical evaluation on coronary stentspdf(101 KB)
December 2008

 

MEDDEV 2.7/2pdf(37 KB) Guide for Competent Authorities in making an assessment of clinical investigation notification
December 2008

 

MEDDEV 2.7/3pdf(166 KB) Clinical investigations: serious adverse event reporting  - SAE reporting formexcel8book(87 KB)
December 2010       

 

 MEDDEV 2.7/4pdf(180 KB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies
December 2010

2.10
Notified bodies

MEDDEV 2.10/2 rev.1pdf(105 KB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
Annex 1pdf(120 KB)Annex 2pdf(14 KB), Annex 3pdf(17 KB), Annex 4pdf(26 KB)
April 2001

2.12
Market surveillance

MEDDEV 2.12/1 rev.8pdf(890 KB)
Guidelines on a Medical Devices Vigilance System  
January 2013  

I. MEDDEV 2.12/1 rev.8  Latest Version Forms
MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active pfd forms
How to use FSCA and MIR formspdf(13 KB)                                                                    
Manufacturer Incident Report - MIRpdf(971 KB) 
Field Safety Corrective Action - FSCApdf(2 MB) 
MIR and FSCA xml fileszip(2 MB)

Other forms and templates
Field Safety Notice Templatemsw8(27 KB)
Trend Report msw8(151 KB)
Periodic Summary Reportmsw8(192 KB)

II. Device Specific Vigilance Guidance

DSVG 00pdf(20 KB)   Introduction to Device Specific Vigilance Guidance 
DSVG 01pdf(22 KB)   Cardiac Ablation Vigilance Reporting Guidance

 

MEDDEV 2.12/2 rev.2 pdf(221 KB) Post Market Clinical Follow-up  studies
January 2012  

2.13
Transitional period

MEDDEV 2.13 rev.1pdf(13 KB) Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) 
August 1998

 

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009pdf(36 KB)

2.14
IVD

MEDDEV 2.14/1 rev.2pdf(75 KB) Borderline and Classification issues. A guide for manufacturers and notified bodies
January 2012

 

MEDDEV 2.14/2 rev.1pdf(64 KB) Research Use Only products
February 2004

 

MEDDEV 2.14/3 rev.1pdf(80 KB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices
January 2007

 

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device
Directive, Article 10msw8(213 KB)

January 2007

 

MEDDEV 2.14/4pdf(115 KB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
January 2012  

2.15
Other guidances

MEDDEV 2.15 rev.3pdf(33 KB) Committees/Working Groups contributing to the implementation of the Medical Device Directives
December 2008