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NHS R&D Forum News

Title: Informal consultation - Medical Device Regulations
Date: 12/03/2012

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 by 10 April 2012.

Further information can be accessed at:

EU Directive 2011/100/EU:

Directive 98/79/EC:

Amendment of Directive 98/79/Ec on In-Vitro Diagnostic Medical Devices - consultation letter:


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