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
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Ⅱ. Device Specific Vigilance Guidance
DSVG Template (22 kB)
New MIR form - as from January 2019
|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|