The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices.
Please note that guidance for stakeholders to implement the medical devices regulations is now available on a dedicated page.
Guidance documents to assist stakeholders in implementing directives related to medical devices.
The MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures.
Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.
See below a complete list of all guidance Meddevs, including links to further information:
|2.1 Scope, field of application, definition||MEDDEV 2.1/1 (18 kB) Definitions of 'medical devices', 'accessory' and 'manufacturer'|
|MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive 'active implantable medical devices'|
|MEDDEV 2.1/2.1 (12 kB) Treatment of computers used to program implantable pulse generators|
|MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative|
|MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment|
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 2009 (28 kB)
|MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function|
|MEDDEV 2.1/6 (514 kB) Qualification and classification of stand alone software|
|2.2 Essential requirements||MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements|
|MEDDEV 2.2/3 rev.3 (17 kB) 'Use by'-date|
|MEDDEV 2.2/4 (38 kB) Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products|
|2.4 Classification of MD||MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices|
|2.5 Conformity assessment procedure||General rules|
Regulatory auditing of quality systems of medical device manufacturers
(See document in the GHTF-global harmonization task force)
|MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related|
|MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure|
|MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers' products)|
|Conformity assessment for particular groups of products|
|MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants|
|MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex|
|MEDDEV 2.5/10 (80 kB) Guideline for authorised representatives|
MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies
MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC
The new SAE reporting form was taken in use by 1 September 2016.
MEDDEV 2.7/4 (183 kB) Guidelines on clinical investigations: a guide for manufacturers and notified bodies
|2.10 Notified bodies||The documents on designation of notified bodies under the new regulations are in the section above (MDCG documents)|
MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of notified bodies within the framework of EC directives on medical devices
MEDDEV 2.12/1 rev.8 (763 kB)
Additional guidance on MEDDEV 2.12/1 rev.8 (855 kB)
Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.
Ⅱ. Device specific vigilance guidance
DSVG Template (22 kB)
New MIR form - as from January 2020
New manufacturer incident report (PDF form)
|MEDDEV 2.12/2 rev.2 (228 kB) Post market clinical follow-up studies|
|2.13 Transitional period||MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)|
|As regards the transitional regime of Directive 2007/47/EC see the interpretative document of the Commission's services of 5 June 2009 (35 kB)|
|2.14 IVD||MEDDEV 2.14/1 rev.2 (76 kB) Borderline and classification issues. A guide for manufacturers and notified bodies|
|MEDDEV 2.14/2 rev.1 (64 kB) Research use only products|
|MEDDEV 2.14/3 rev.1 (80 kB) Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices|
|Form for the registration of manufacturers and devices in vitro diagnostic medical device|
directive, article 10 (213 kB)
|MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP|
|MEDDEV 2.15 rev.3 (32 kB) Committees/working groups contributing to the implementation of the medical device directives|