Europe Medical Device Regulations

All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Europe, you may be interested in our custom regulatory strategy reports for Europe. This is not a complete list. See the EC website regulatory section pertaining to medical devices.

Final version of the European Medical Device and IVD Regulations published on 5 May 2017

MDD 93/42/EEC

CONSOLIDATED Medical Device Directive (93/42/EEC) (Interactive Web page. Downloadable .pdf document of the MDD 93/42/EEC also available.)

In-Vitro Diagnostic Devices Directive (98/79/EC)

Directive 98/79/EC on In Vitro Diagnostic Medical Devices (Interactive Web page. Downloadable .pdf document of the In-Vitro Diagnostic Devices Directive (98/79/EC) also available.)

Vigilance Contact Points

Vigilance Contact Points Within The National Competent Authorities (opens in a new window - link to EU Commission Website)

Major Regulations


Document	Language	Number	Published
* Europe Medical Devices Regulation	en	MDR	05/2017
** Europe IVD Regulation	en	IVDR	05/2017
European Active Implantable Medical Devices Directive (AIMDD)	en	90/385/EEC	06/1990
European Cosmetic Products Directive	en	1223/2009	11/2009
European In-Vitro Diagnostic Devices Directive (IVDD)	en	98/79/EC	10/1998
European Medical Devices Directive (MDD)	en	93/42/EEC	06/1993
European Personal Protective Equipment Directive	en	89/686/EEC	12/1989
Regulation amending the European MDD 93/42/EEC and others	en	2007/47/EC	9/2007

General Guidance Documents


Document	Language	Number	Published
EU - GHTF Guidelines for Auditing Mfg Control of Supplier - Part 5	en	GHTF/SG4/N84:2010	08/2010
EU - GHTF Guidelines for Multi-Site Auditing of QMS Part 4	en	GHTF/SG4/N83:2010	08/2010
Interpretation of implementation of Directive 2007/47/EC	en	2007/47/EC	06/2009
MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer	en	2.1/1	04/1994
MEDDEV 2.12-2 rev 2 - Post market clinical follow up for medical devices	en	2.12-2 rev 2	01/2012
MEDDEV 2.2/1 rev 1 - Addresses EMC requirements	en	2.2/1 rev 1	02/1998
MEDDEV 2.2/3 rev 3 - Discusses the Use By date	en	2.2/3 rev 3	06/1998
MEDDEV 2.2/4 - Conformity Assessment of IVF and ART Products	en	2.2/4	01/2012
MEDDEV 2.4/1 rev 9 - Classification of medical devices	en	2.4/1 rev 9	06/2010
MEDDEV 2.5/3 rev 2 - When a quality-related inspection of a subcontractor is needed	en	2.5/3 rev 2	06/1998
MEDDEV 2.1/2 rev 2 - Application of the Active Implantable Device Directive	en	2.1/2 rev 2	04/1994
MEDDEV 2.1/3 rev 3 - Demarcation between MDD and Medicinal Products Directive	en	2.1/3 rev 3	12/2009
MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives	en	2.1/4	03/1994
MEDDEV 2.1/5 - Addresses medical devices with a measuring function	en	2.1/5	06/1998
MEDDEV 2.10/2 rev 1 - Designation and monitoring of Notified Bodies	en	2.10/2 rev 1	04/2001
MEDDEV 2.12-1 rev 8 - Guidelines on a medical devices vigilance system	en	2.12-1 rev 8	01/2013
MEDDEV 2.14/1 rev 2 - Borderline issues between the IVD and Medical Device Directives	en	2.14/1 rev 2	01/2012
MEDDEV 2.14/2 rev 1 - Dealing with IVD products for research use only	en	2.14/2 rev 1	02/2004
MEDDEV 2.14/3 rev 1 - Requirements for e-labeling of IVDs	en	2.14/3 rev 1	01/2007
MEDDEV 2.15 rev 3 - Committees and organizations related to medical devices	en	2.15 rev 3	12/2008
MEDDEV 2.5/10 - Guideline For Authorised Representatives	en	2.5/10	01/2012
MEDDEV 2.5/5 rev 3 - Clarifies translation procedures	en	2.5/5 rev 3	02/1998
MEDDEV 2.5/6 rev 1 - Defines homogeneity of production batches	en	2.5/6 rev 1	02/1998
MEDDEV 2.5/9 rev 1 - Medical devices containing natural rubber latex	en	2.5/9 rev 1	02/2004
MEDDEV 2.7/1 rev 4 - Clinical Evaluation: Guide For Manufacturers And Notified Bodies	en	2.7/1 rev 4	06/2016
MEDDEV 2.7/2 - Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 93/42/EEC and 90/385/EEC	en	2.7/2 rev 2	09/2015
MEDDEV 2.7/4 - Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies	en	2.7/4	12/2010
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices	en	1.19	04/2018
NBOG - Certificates Issued by Notified Bodies Reference to Council Directives 2010-3	en	2010-3	2010
NBOG - Guidance for Notified Bodies Auditing Suppliers	en	2010-1	2010
NBOG - Guidance on Audit Report Content	en	2010-2	2010

Specific Guidance Documents


Document	Language	Number	Published
EU Commission Regulation 920/2013 on the Designation and Supervision of Notified Bodies	en	920/2013	09/2013
MEDDEV 2.5-7 rev 1 - Discusses conformity assessment for breast implants	en	2.5-7 rev 1	07/1998
MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators	en	2.1/2.1	02/1998
MEDDEV 2.1/6 - Qualification and Classification of Stand Alone Software	en	2.1/6	07/2016
MEDDEV 2.11/1 rev 2 - Risk management in animal tissue products - TSE	en	2.11/1 rev 2	01/2008
MEDDEV 2.14/4 - CE marking of blood based IVD medical devices for vCJD	en	2.14/4	01/2012
MEDDEV 2.7/3 - Clinical investigations: serious adverse event reporting	en	2.7/3	05/2015

Additional Information


Document	Language	Number	Published
Blue Guide on the implementation of EU product rules	en	C 272/01	07/2016
COMMISSION REGULATION (EU) - E-labeling regulations	en	207/2012	03/2012
EU Commission Recommendation Regarding Unannounced Audits	en	2013/473/EU	09/2013
NBOG - Checklist for audit or Notified Body review of clinical data/evaluation	en	CL 2010-1	2010

Medical Device Regulations in Europe