Informal consultation - update to Medical Device Regulations

The MHRA is seeking views on the approach to implementing EU Directive 2011/100/EU. This Directive amends Directive 98/79/EC on in-vitro diagnostic medical devices to reclassify diagnostic assays used to identify the presence of variant Creutzfeldt-Jakob Disease (vCJD) in human blood supplies into the regulatory category subject to the highest possible level of scrutiny.

Responses are requested by email to graeme.tunbridge@mhra.gsi.gov.uk by 10 April 2012.

Further information can be accessed at:

EU Directive 2011/100/EU: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0050:0051:EN:PDF

Directive 98/79/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20031120:en:PDF

Amendment of Directive 98/79/Ec on In-Vitro Diagnostic Medical Devices - consultation letter: http://www.mhra.gov.uk/home/groups/comms-ic/documents/regulatorynews/con146622.pdf