The consultation process seeks public views related to a legislative proposal that addresses:
- 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
The Ombu Library has a copy of the document that describes the specific issues the commission wishes to address.
You should submit comments by September 15, 2010.
Submit comments on 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
E-mail: SANCO-IVD-REVISION@ec.europa.eu
You can obtain further information from the European Commission website at: http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4404&tpa_id=164&lang=en