MedDev's 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.
Documents correct as of 12/11/04, please check the European Commission's Website for the most up to date versions.
For more information about the European Commission guidance documents, please Contact Us.
