European Medical Device Regulations
We have assembled the following documents as a service to the medical device community. All documents were published by the European Parliament or European Commission and are in PDF format. If you find a newer version of a document or one that should be included, please email us.
Directives:
GUIDANCE Document on Interpreting Directive 2007/47/EC
CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
CONSOLIDATED Cosmetic Products Directive (76/768/EEC)
CONSOLIDATED Medical Device Directive (93/42/EEC)
In-Vitro Diagnostic Devices Directive (98/79/EC)
Personal Protective Equipment Directive (89/686/EEC)
MEDDEV Guidance Documents:
- MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer
- MEDDEV 2.1/2 REV 2 - Application of the Active Implantable Device Directive
- MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators
- MEDDEV 2.1/3 REV 2 - Demarcation between MDD and Medicinal Products Directive
- MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives
- MEDDEV 2.1/5 - Addresses medical devices with a measuring function
- MEDDEV 2.10-2 REV 1 - Designation and monitoring of Notified Bodies
- MEDDEV 2.11/1 REV 2 - Risk management in animal tissue products - TSE
- MEDDEV 2.12-1 REV 6 - Guidelines on a medical devices vigilance system
- MEDDEV 2.12-2 - Post market clinical follow up for medical devices
- MEDDEV 2.14/1 REV 1 - Borderline issues between the IVD and Medical Device Directives.
- MEDDEV 2.14/2 REV 1 - Dealing with IVD products for research use only
- MEDDEV 2.14/3 REV 1 - Requirements for e-labeling of IVDs
- MEDDEV 2.15/2 REV 2 - Committees and organizations related to medical devices
- MEDDEV 2.2/1 REV 1 - Addresses EMC requirements
- MEDDEV 2.2/3 REV 3 - Discusses the "Use By" date
- MEDDEV 2.4/1 REV 9 - Classification of medical devices - UPDATED JUNE 2010
- MEDDEV 2.5-7 REV 1 - Discusses conformity assessment for breast implants
- MEDDEV 2.5-8 REV 2 - Deals with assessment of devices with animal materials
- MEDDEV 2.5/3 REV 2 - When a quality-related inspection of a subcontractor is needed
- MEDDEV 2.5/5 REV 3 - Clarifies translation procedures
- MEDDEV 2.5/6 REV 1 - Defines homogeneity of production batches
- MEDDEV 2.5/9 REV 1 - Medical devices containing natural rubber latex
- MEDDEV 2.7.1 REV 3 - Clinical data, a guide for manufacturers and Notified Bodies
- Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices - Version 1.6 February 2010
Presentations:
NEW - Watch our 7 minute Flash presentation that fully explains the European CE Marking process. Requires audio.
EU Vigilance Contacts:
Search medical device vigilance contact points within National Ministries of Health and Competent Authorites.
