EC Proposes Adding vCJD Assays to IVD Directive Annex II List A

Assays for blood screening, diagnosis and confirmation of variant Creutzfeldt-Jakob disease (vCJD) will have to comply with specific performance requirements to get a CE mark if they are included on Annex II List A of the EU’s in vitro diagnostic (IVD) Directive. Following a request from the UK, the European Commission has proposed adding the assays to the list in a draft amendment to the IVD Directive. The performance requirements will be spelled out in a common technical specification, which is expected to be published, along with a guidance document, in July, according to the Irish Medicines Board.
International Medical Device Regulatory Monitor