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EU Guidance on 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 recognized 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.


Regulatory Agencies

MedDev Guidance (EU)

MedDev Guidance       (US-FDA)





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  


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 

Classification of MD

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


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


Evaluation of medical devices incorporating products of animal origin.                                                                         
(See MEDDEV 2.11/1 rev.2pdf(82 KB))


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  


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


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

Market surveillance

MEDDEV 2.12/1 rev.8pdf(745 KB) Medical Devices Vigilance System  
January 2013                                                                                 
Manufacturer Incident Reportpdf(971 KB) 
How to use the MIRpdf(13 KB)
Field Safety Corrective Actionpdf(2 MB) 
Trend Reportmsw8(151 KB)
Periodic Summary Reportmsw8(192 KB)
MIR and FSCA xml files
zip(2 MB)


List of contact points


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


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)


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  

Other guidances

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