Europe 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.

MDD 93/42/EEC

• CONSOLIDATED Medical Device Directive (93/42/EEC) (Interactive Web page. Downloadable .pdf document of theMDD 93/42/EEC 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

• 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)

General 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 3 - 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
• MEDDEV 2.5/6 REV 1 - Defines homogeneity of production batches
• MEDDEV 2.5-7 REV 1 - Discusses conformity assessment for breast implants
• 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 2.5/9 REV 1 - Medical devices containing natural rubber latex
• MEDDEV 2.7.1 REV 3 - Talks about evaluation of medical device clinical data
• MEDDEV 2.7/4 - Guidance on Clinical Evaluation Reports
• GUIDANCE Document on Intepreting Directive 2007/47/EC
• Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices - VER1.11
• EU - GHTF Guidelines Regulatory Auditing of QMS Parts 4
• EU - GHTF Guidelines Regulatory Auditing of QMS Parts 5
• NBOG - Guidance for Notified Bodies Auditing Suppliers 2010-1
• NBOG - Guidance on Audit Report Content 2010-2
• NBOG - Certificates Issued by Notified Bodies Reference to Council Directives 2010-3

Forms and Applications

• NBOG - Checklist for audit or Notified Body review of clinical data/evaluation