Medical Device Regulations in Europe

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 Please help us maintain this list by reporting outdated or missing documents.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

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

Vigilance Contact Points

Major Regulations
Document Number Published Language
Download * Europe Medical Devices Regulation MDR 05/2017 English
Download European In-Vitro Diagnostic Devices Directive (IVDD) 98/79/EC 12/2011 English
Download ** Europe IVD Regulation IVDR 05/2017 English
Download European Cosmetic Products Directive 1223/2009 11/2009 English
Download European Personal Protective Equipment Directive 89/686/EEC 12/1989 English
Download Regulation amending the European MDD 93/42/EEC and others 2007/47/EC 9/2007 English
Download European Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC 06/1990 English
Download European Medical Devices Directive (MDD) 93/42/EEC 06/1993 English
General Guidance Documents
Document Number Published Language
Download Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices 1.19 04/2018 English
Download MEDDEV 2.2/1 rev 1 - Addresses EMC requirements 2.2/1 rev 1 02/1998 English
Download MEDDEV 2.1/3 rev 3 - Demarcation between MDD and Medicinal Products Directive 2.1/3 rev 3 12/2009 English
Download MEDDEV 2.7/1 rev 4 - Clinical Evaluation: Guide For Manufacturers And Notified Bodies 2.7/1 rev 4 06/2016 English
Download 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 2.7/2 rev 2 09/2015 English
Download MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer 2.1/1 04/1994 English
Download MEDDEV 2.1/2 rev 2 - Application of the Active Implantable Device Directive 2.1/2 rev 2 04/1994 English
Download MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives 2.1/4 03/1994 English
Download MEDDEV 2.1/5 - Addresses medical devices with a measuring function 2.1/5 06/1998 English
Download MEDDEV 2.2/3 rev 3 - Discusses the Use By date 2.2/3 rev 3 06/1998 English
Download MEDDEV 2.2/4 - Conformity Assessment of IVF and ART Products 2.2/4 01/2012 English
Download MEDDEV 2.4/1 rev 9 - Classification of medical devices 2.4/1 rev 9 06/2010 English
Download MEDDEV 2.5/3 rev 2 - When a quality-related inspection of a subcontractor is needed 2.5/3 rev 2 06/1998 English
Download MEDDEV 2.5/5 rev 3 - Clarifies translation procedures 2.5/5 rev 3 02/1998 English
Download MEDDEV 2.5/6 rev 1 - Defines homogeneity of production batches 2.5/6 rev 1 02/1998 English
Download MEDDEV 2.5/10 - Guideline For Authorised Representatives 2.5/10 01/2012 English
Download MEDDEV 2.7/4 - Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies 2.7/4 12/2010 English
Download MEDDEV 2.10/2 rev 1 - Designation and monitoring of Notified Bodies 2.10/2 rev 1 04/2001 English
Download MEDDEV 2.12-2 rev 2 - Post market clinical follow up for medical devices 2.12-2 rev 2 01/2012 English
Download MEDDEV 2.12-1 rev 8 - Guidelines on a medical devices vigilance system 2.12-1 rev 8 01/2013 English
Download MEDDEV 2.14/1 rev 2 - Borderline issues between the IVD and Medical Device Directives 2.14/1 rev 2 01/2012 English
Download MEDDEV 2.14/2 rev 1 - Dealing with IVD products for research use only 2.14/2 rev 1 02/2004 English
Download MEDDEV 2.14/3 rev 1 - Requirements for e-labeling of IVDs 2.14/3 rev 1 01/2007 English
Download MEDDEV 2.5/9 rev 1 - Medical devices containing natural rubber latex 2.5/9 rev 1 02/2004 English
Download MEDDEV 2.15 rev 3 - Committees and organizations related to medical devices 2.15 rev 3 12/2008 English
Download NBOG - Certificates Issued by Notified Bodies Reference to Council Directives 2010-3 2010-3 2010 English
Download NBOG - Guidance on Audit Report Content 2010-2 2010 English
Download NBOG - Guidance for Notified Bodies Auditing Suppliers 2010-1 2010 English
Download EU - GHTF Guidelines for Auditing Mfg Control of Supplier - Part 5 GHTF/SG4/N84:2010 08/2010 English
Download EU - GHTF Guidelines for Multi-Site Auditing of QMS Part 4 GHTF/SG4/N83:2010 08/2010 English
Download Interpretation of implementation of Directive 2007/47/EC 2007/47/EC 06/2009 English
Specific Guidance Documents
Document Number Published Language
Download MEDDEV 2.1/6 - Qualification and Classification of Stand Alone Software 2.1/6 07/2016 English
Download MEDDEV 2.7/3 - Clinical investigations: serious adverse event reporting 2.7/3 05/2015 English
Download MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators 2.1/2.1 02/1998 English
Download MEDDEV 2.5-7 rev 1 - Discusses conformity assessment for breast implants 2.5-7 rev 1 07/1998 English
Download MEDDEV 2.11/1 rev 2 - Risk management in animal tissue products - TSE 2.11/1 rev 2 01/2008 English
Download MEDDEV 2.14/4 - CE marking of blood based IVD medical devices for vCJD 2.14/4 01/2012 English
Download EU Commission Regulation 920/2013 on the Designation and Supervision of Notified Bodies 920/2013 09/2013 English
Additional Information
Document Number Published Language
Download Blue Guide on the implementation of EU product rules C 272/01 07/2016 English
Download NBOG - Checklist for audit or Notified Body review of clinical data/evaluation CL 2010-1 2010 English
Download COMMISSION REGULATION (EU) - E-labeling regulations 207/2012 03/2012 English
Download EU Commission Recommendation Regarding Unannounced Audits 2013/473/EU 09/2013 English