Medical Device Regulations in Europe

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 Please help us maintain this list by reporting outdated or missing documents.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

MDD 93/42/EEC

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

Vigilance Contact Points

Major Regulations

DocumentLanguageNumberPublished
* Europe Medical Device Regulation - Consolidated Negotiated Texten MDR06/2016
** Europe IVD Regulation - Consolidated Negotiated Texten IVDR06/2016
European Active Implantable Medical Devices Directive (AIMDD)en 90/385/EEC06/1990
European Cosmetic Products Directiveen 1223/200911/2009
European In-Vitro Diagnostic Devices Directive (IVDD)en 98/79/EC10/1998
European Medical Devices Directive (MDD)en 93/42/EEC06/1993
European Personal Protective Equipment Directiveen 89/686/EEC12/1989
Regulation amending the European MDD 93/42/EEC and othersen 2007/47/EC9/2007

General Guidance Documents

DocumentLanguageNumberPublished
EU - GHTF Guidelines for Auditing Mfg Control of Supplier - Part 5en GHTF/SG4/N84:201008/2010
EU - GHTF Guidelines for Multi-Site Auditing of QMS Part 4en GHTF/SG4/N83:201008/2010
Interpretation of implementation of Directive 2007/47/ECen 2007/47/EC06/2009
MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufactureren 2.1/104/1994
MEDDEV 2.12-2 rev 2 - Post market clinical follow up for medical devicesen 2.12-2 rev 201/2012
MEDDEV 2.2/1 rev 1 - Addresses EMC requirementsen 2.2/1 rev 104/1994
MEDDEV 2.2/3 rev 3 - Discusses the Use By dateen 2.2/3 rev 306/1998
MEDDEV 2.2/4 - Conformity Assessment of IVF and ART Productsen 2.2/401/2012
MEDDEV 2.4/1 rev 9 - Classification of medical devicesen 2.4/1 rev 9 06/2010
MEDDEV 2.5/3 rev 2 - When a quality-related inspection of a subcontractor is neededen 2.5/3 rev 206/1998
MEDDEV 2.1/2 rev 2 - Application of the Active Implantable Device Directiveen 2.1/2 rev 204/1994
MEDDEV 2.1/3 rev 3 - Demarcation between MDD and Medicinal Products Directiveen 2.1/3 rev 303/2010
MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directivesen 2.1/403/1994
MEDDEV 2.1/5 - Addresses medical devices with a measuring functionen 2.1/506/1998
MEDDEV 2.10/2 rev 1 - Designation and monitoring of Notified Bodiesen 2.10/2 rev 104/2001
MEDDEV 2.12-1 rev 8 - Guidelines on a medical devices vigilance systemen 2.12-1 rev 801/2013
MEDDEV 2.14/1 rev 2 - Borderline issues between the IVD and Medical Device Directivesen 2.14/1 rev 201/2012
MEDDEV 2.14/2 rev 1 - Dealing with IVD products for research use onlyen 2.14/2 rev 1 02/2004
MEDDEV 2.14/3 rev 1 - Requirements for e-labeling of IVDsen 2.14/3 rev 101/2007
MEDDEV 2.15 rev 3 - Committees and organizations related to medical devicesen 2.15 rev 312/2008
MEDDEV 2.5/10 - Guideline For Authorised Representativesen 2.5/1001/2012
MEDDEV 2.5/5 rev 3 - Clarifies translation proceduresen 2.5/5 rev 302/1998
MEDDEV 2.5/6 rev 1 - Defines homogeneity of production batchesen 2.5/6 rev 102/1998
MEDDEV 2.5/9 rev 1 - Medical devices containing natural rubber latexen 2.5/9 rev 1 02/2004
MEDDEV 2.7/1 rev 4 - Clinical Evaluation: Guide For Manufacturers And Notified Bodiesen 2.7/1 rev 406/2016
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/EECen 2.7/2 rev 209/2015
MEDDEV 2.7/4 - Guidelines on Clinical Investigation: A guide for manufacturers and notified bodiesen 2.7/4 12/2010
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devicesen 1.1709/2015
NBOG - Certificates Issued by Notified Bodies Reference to Council Directives 2010-3en 2010-32010
NBOG - Guidance for Notified Bodies Auditing Suppliers en 2010-12010
NBOG - Guidance on Audit Report Content en 2010-22010

Specific Guidance Documents

DocumentLanguageNumberPublished
EU Commission Regulation 920/2013 on the Designation and Supervision of Notified Bodiesen 920/201309/2013
MEDDEV 2.5-7 rev 1 - Discusses conformity assessment for breast implantsen 2.5-7 rev 1 07/1998
MEDDEV 2.1/2.1 - Computers used to program implantable pulse generatorsen 2.1/2.102/1998
MEDDEV 2.1/6 - Qualification and Classification of Stand Alone Softwareen 2.1/6 01/2012
MEDDEV 2.11/1 rev 2 - Risk management in animal tissue products - TSEen 2.11/1 rev 201/2008
MEDDEV 2.14/4 - CE marking of blood based IVD medical devices for vCJDen 2.14/401/2012
MEDDEV 2.7/3 - Clinical investigations: serious adverse event reportingen 2.7/305/2015

Additional Information

DocumentLanguageNumberPublished
Blue Guide on the implementation of EU product rulesen Ver 1.107/2015
COMMISSION REGULATION (EU) - E-labeling regulationsen 207/201203/2012
EU Commission Recommendation Regarding Unannounced Audits en 2013/473/EU09/2013
NBOG - Checklist for audit or Notified Body review of clinical data/evaluationen CL 2010-12010