European Commission Public Consultation on the revision of the In-vitro Diagnostic Medical Devices Directive (98/79/EC)
05 July 2010
The European Commission has launched a public consultation on the technical aspects of the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices.
Under the consultation process the views of the public and interested parties are sought in relation to the legislative proposal which addresses issues such as:-
- Classification of IVDs
- Conformity assessment procedures applicable to IVDs
- Scope of IVD types subject to the requirements of the IVD Directive
- Clinical evidence for IVDs
Any comments on this public consultation should be submitted by mail, fax or email to: European Commission Health and Consumers Directorate-General (DG SANCO) Unit SANCO B2, Cosmetics and Medical Devices B-1049 Brussels - Belgium, Fax: 00 32 (0) 2 296 64 67, Email: SANCO-IVD-REVISION@ec.europa.eu. Respondents may also provide a copy of their feedback to the IMB (medicaldevices@imb.ie) and the IMB will consider this feedback in our own response to the European Commission.
The consultation process is open for submissions until 15 September 2010.
Further information on the public consultation process may be obtained from the European Commission website at the following link: http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4404&tpa_id=164&lang=en