Medical Device Regulations in Europe
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 Please help us maintain this list by reporting outdated or missing documents.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.
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 | 12/2011 |
| 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 |