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 If you would like to suggest a document for inclusion or we have included an outdated version, please email us.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:
ORIGINAL Medical Device Directive (MDD 93/42/EEC)
Full text of the original MDD. Amended by 2007/47/EC. Consolidated version below.
CONSOLIDATED Medical Device Directive (93/42/EEC)
This version includes changes made to the MDD by Directive 2007/47/EC.
ORIGINAL Active Implantable Medical Devices Directive (90/385/EEC)
Full text of original AIMDD. Amended by 2007/47/EC. Consolidated version below.
CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
This version includes changes made to the AIMDD by Directive 2007/47/EC.
In-Vitro Diagnostic Devices Directive (IVDD)
Full text of the European IVD Directive 98/79/EC.
Personal Protective Equipment Directive (PPE)
Full text of the European directive 89/686/EEC that governs personal protective equipment.
MEDDEV GUIDANCE DOCUMENTS:
MEDDEV 2.1/1 - Defines Medical Devices, Accessories and Manufacturer.
MEDDEV 2.2/1 REV 1 - Addresses EMC requirements.
MEDDEV 2.1/2.1 - Computers used to program implantable pulse generators.
MEDDEV 2.1/2 REV 2 - Application of the Active Implantable Device Directive.
MEDDEV 2.1/3 REV 2 - Demarcation between MDD and Medicinal Products Directive.
MEDDEV 2.2/3 REV 3 - Discusses the "Use By" date.
MEDDEV 2.1/4 - Discusses demarcation between the EMC and PPE Directives.
MEDDEV 2.1/5 - Addresses medical devices with a measuring function.
MEDDEV 2.4/1 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 2.5/9 REV 1 - Medical devices containing natural rubber latex.
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 2.5-8 REV 2 - Deals with assessment of devices with animal materials.
MEDDEV 2.7.1 - Talks about evaluation of medical device clinical data.
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 2.14/2 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 - Different committees or organizations related to medical devices.
Guidance on reclassification of hip, knee and shoulder implants. January 2007.
