The new Guidance Document (MEDDEV) on the classification of Medical Devices has been published in 2010 by the European Commission, DG HEALTH AND CONSUMER Directorate B, Unit B2 “Cosmetics and medical devices”.
Here is the Foreword of MEDDEV 2. 4/1 Rev 9., published on June 2010: The present MEDDEV is part of a set of guidelines relating to questions of application of EU Directives on medical devices. They are not legally binding. Only the European Court of Justice can give an authoritative interpretation of Community Law.
This MEDDEV contains guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC, as amended. It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis.
Directive 93/42/EEC, as amended, allows for derogation from the classification rules outlined in its Annex IX in light of technical progress or on information gathered from post-market experience with the device.
This MEDDEV has been revised after consultation with various interested parties (e.g. Competent Authorities, Commission services, industry and other Stakeholders) and therefore this document reflect a consensus view on the classification of medical devices.
Active implantable medical devices and in vitro diagnostic medical devices are covered by separate Directives, which do not apply the classification rules reviewed in this MEDDEV.
Note: This document is a revision of an earlier document published in July 2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to the changes in classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001, including derogation of the classification rules in the case of breast implants and hip, knee and shoulder joint replacements and requirements related to devices containing human blood derivatives and medical devices manufactured utilizing tissues of animal origin. In addition this guidance document takes account of the changes arising from Directive 2007/47/EC2 which further amends Directive 93/42/EEC and became applicable as from 21st March 2010.
If you have any additional questions regarding these and other changes please feel free to contact us.