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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, definitionMEDDEV 2.1/1pdf(19 kB) Choose translations of the previous link  Definitions of “medical devices”, “accessory” and “manufacturer”
April 1994
MEDDEV 2.1/2 rev.2pdf(15 kB) Choose translations of the previous link  Field of application of directive “active implantable medical devices”
April 1994
MEDDEV 2.1/2.1pdf(13 kB) Choose translations of the previous link  Field of application of directive “active implantable medical devices”
February 1998
MEDDEV 2.1/3 rev.3pdf(187 kB) Choose translations of the previous link  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(22 kB) Choose translations of the previous link  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(33 kB) Choose translations of the previous link 
MEDDEV 2.1/5pdf(11 kB) Choose translations of the previous link  Medical devices with a measuring function
June 1998
MEDDEV 2.1/6pdf(331 kB) Choose translations of the previous link  Qualification and Classification of stand alone software
January 2012
2.2 Essential requirementsMEDDEV 2.2/1 rev.1pdf(17 kB) Choose translations of the previous link  EMC requirements
February 1998
MEDDEV 2.2/3 rev.3pdf(17 kB) Choose translations of the previous link  “Use by”-date
June 1998
MEDDEV 2.2/4pdf(40 kB) Choose translations of the previous link  Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
January 2012
2.4 Classification of MDMEDDEV 2.4/1 rev.9pdf(669 kB) Choose translations of the previous link  Classification of medical devices
June 2010
2.5 Conformity assessment procedureGeneral 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) Choose translations of the previous link  Subcontracting quality systems related
June 1998
MEDDEV 2.5/5 rev.3pdf(7 kB) Choose translations of the previous link  Translation procedure
February 1998
MEDDEV 2.5/6 rev.1pdf(10 kB) Choose translations of the previous link  Homogenous batches (verification of manufacturers' products)
February 1998
Conformity assessment for particular groups of products
MEDDEV 2.5/7 rev.1pdf(95 kB) Choose translations of the previous link  Conformity assessment of breast implants
July 1998
MEDDEV 2.5/9 rev.1pdf(99 kB) Choose translations of the previous link  Evaluation of medical devices incorporating products containing natural rubber latex
February 2004
MEDDEV 2.5/10pdf(80 kB) Choose translations of the previous link  Guideline for Authorised Representatives
January 2012

2.7
Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev.3pdf(387 kB) Choose translations of the previous link  Clinical evaluation: Guide for manufacturers and notified bodies
December 2009
Appendix 1: Clinical evaluation on coronary stentspdf(103 kB) Choose translations of the previous link 
December 2008

 

MEDDEV 2.7/2pdf(38 kB) Choose translations of the previous link  Guide for Competent Authorities in making an assessment of clinical investigation notification
December 2008

 

MEDDEV 2.7/3pdf(170 kB) Choose translations of the previous link  Clinical investigations: serious adverse event reporting  - SAE reporting formexcel8book(90 kB)
December 2010       

 

 MEDDEV 2.7/4pdf(185 kB) Choose translations of the previous link  Guidelines on Clinical investigations: a guide for manufacturers and notified bodies
December 2010

2.10 Notified bodiesMEDDEV 2.10/2 rev.1pdf(107 kB) Choose translations of the previous link  Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
Annex 1pdf(123 kB) Choose translations of the previous link , Annex 2pdf(15 kB) Choose translations of the previous link , Annex 3pdf(17 kB) Choose translations of the previous link , Annex 4pdf(27 kB) Choose translations of the previous link 
April 2001
2.12
Market surveillance

MEDDEV 2.12/1 rev.8pdf(911 kB) Choose translations of the previous link 
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 PDF forms
How to use FSCA and MIR formspdf(13 kB) Choose translations of the previous link 
Manufacturer Incident Report - MIRpdf(994 kB) Choose translations of the previous link 
Field Safety Corrective Action - FSCApdf(2 MB) Choose translations of the previous link 
MIR and FSCA xml fileszip(2 MB)

Other forms and templates
Field Safety Notice Templatemsw8(28 kB) Choose translations of the previous link 
Trend Report msw8(155 kB) Choose translations of the previous link 
Periodic Summary Reportmsw8(197 kB) Choose translations of the previous link 

Ⅱ. Device Specific Vigilance Guidance

DSVG 00pdf(21 kB) Choose translations of the previous link  Introduction to Device Specific Vigilance Guidance
DSVG 01pdf(22 kB) Choose translations of the previous link  Cardiac Ablation Vigilance Reporting Guidance

MEDDEV 2.12/2 rev.2pdf(227 kB) Choose translations of the previous link  Post Market Clinical Follow-up studies
January 2012
2.13 Transitional periodMEDDEV 2.13 rev.1pdf(14 kB) Choose translations of the previous link  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(37 kB) Choose translations of the previous link 
2.14 IVDMEDDEV 2.14/1 rev.2pdf(77 kB) Choose translations of the previous link  Borderline and Classification issues. A guide for manufacturers and notified bodies
January 2012
MEDDEV 2.14/2 rev.1pdf(66 kB) Choose translations of the previous link  Research Use Only products
February 2004
MEDDEV 2.14/3 rev.1pdf(82 kB) Choose translations of the previous link  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 10
msw8(219 kB)
Choose translations of the previous link 
January 2007
MEDDEV 2.14/4pdf(118 kB) Choose translations of the previous link  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(34 kB) Choose translations of the previous link  Committees/Working Groups contributing to the implementation of the Medical Device Directives
December 2008