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European Medical Device Regulations
Europe
All regulatory documents shown below were published by the European Parliament or European Commission and are in PDF format. Please help us maintain this list by reporting outdated or missing documents.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.
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
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- CONSOLIDATED Cosmetic Products Directive (76/768/EEC)
- CONSOLIDATED Medical Device Directive (93/42/EEC) | View as web page
- In-Vitro Diagnostic Devices Directive (98/79/EC) | View as web page
- 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 2.1/6 - Qualification and Classification of Stand Alone Software
- MEDDEV 2.2/1 REV 1 - Addresses EMC requirements
- MEDDEV 2.2/3 REV 3 - Discusses the "Use By" date
- MEDDEV 2.2/4 - Conformity Assessment of IVF and ART Products
- MEDDEV 2.4/1 REV 9 - Classification of medical devices
- 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 2.5-7 REV 1 - Discusses conformity assessment for breast implants
- MEDDEV 2.5/9 REV 1 - Medical devices containing natural rubber latex
- MEDDEV 2.5/10 - Guideline For Authorised Representatives
- MEDDEV 2.7.1 REV 3 - Clinical Evaluation: A Guide For Manufacturers And Notified Bodies
- MEDDEV 2.7/4 - Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies
- 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 8 - Guidelines on a medical devices vigilance system
- MEDDEV 2.12-2 rev 2 - Post market clinical follow up for medical devices
- MEDDEV 2.14/1 REV 2 - 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 2.14/4 - CE marking of blood based IVD medical devices for vCJD
- MEDDEV 2.15/2 REV 3 - Committees and organizations related to medical devices
- COMMISSION REGULATION (EU) No 207/2012 - E-labeling regulations
- GUIDANCE Document on Intepreting Directive 2007/47/EC
- Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices - VER 1.13
- 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
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