The Commission of the European Union (EU) has amended its Directive 98/79/EC on in-vitro medical devices. Published in December 2011 in the Official Journal of the European Union, the Commission’s action adds assays for blood screening, diagnosis and confirmation of “Variant Creutzfeldt-Jakob disease” (vCJD) to List A of Annex II of the Directive. The change was made at the request of the United Kingdom.
Read the complete text regarding amendments to the EU’s In-Vitro Medical Devices Directive.
