European Medical Device Regulations
We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are current, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please email us. All documents were published by the European Parliament or European Commission and are in PDF format unless otherwise noted.
Directives:
- 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 (IVDD)
- Personal Protective Equipment Directive (PPE)
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 1 - Risk management in animal tissue products - TSE
- MEDDEV 2.12-1 REV 5 - 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 2.14/1 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 8 PART 1 - Classification of medical devices. Part 1 of 2
- MEDDEV 2.4/1 REV 8 PART 2 - Classification of medical devices. Part 2 of 2
- 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 - Talks about evaluation of medical device clinical data
