This section will be regularly updated with topical documents.
Documents correct as of 12/11/06; please check the European Commission's website for the most up to date versions.
European Commission Guidance Documents
MedDevs are guidance documents issued by the European Commission to provide manufacturers and Notified Bodies assistance in understanding the requirements of the medical devices directive.
- MedDev.2.1-3 0701 Rev.2 Provides guidance on whether products are covered by the medical devices directives or should be treated as medicines, and also the consultation process that a Notified Body must follow with a medicines Competent Authority when a medical device incorporates a medicinal substance.
- MedDev.2.5-5 0598 Rev.1 The Global Harmonization Task Force (GHTF) document on quality management systems to medical devices regulations.
- MedDev.2.4-1 0701 Rev.8 Part 1 MedDev.2.4-1 0701 Rev.8 Part 2 This two part document provides clear guidance on the classification rules of the Medical Devices Directive, includes examples and decision trees.
- MedDev.2.12-1 0401 Rev.4 Part 1 MedDev.2.12-1 0401 Rev.4 Part 2 This two part document provides guidance on the implementation of a vigilance reporting system, to report incidents to the European Competent Authorities, includes suggested formats for reports and contact details of Competent Authorities.
- MedDev.2.1-4 0394 Provides guidance on the borderlines between the medical devices directives and the PPE & EMC Directives.
- MedDev.2.1-5 0698 Provides guidance regarding devices with mearsuring functions.
- MedDev.2.2-3 0698 Rev.3 Provides guidance on the requirement for "use by" dates on medical devices.
- MedDev.2.2-1 0298 Provides guidance on EMC requirements for medical devices.
- MedDev.2.5-8 0299 Rev.2 Guidlines on devices incorporating animal tissues or derived materials.
- MedDev Guidance on the homogeneous batches.
