Medical Devices

Extension to Presafe Denmark A/S' accreditation

Presafe Denmark A/S has obtained an extension to its existing accreditation according to 17021:2011 and can now carry out certifications according to the new edition of DS/EN ISO 13485:2012.

IVD Directive 98/79/EC new listings to List A of annex II

"Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation" has been added to List A of Annex II in the IVD Directive 98/79/EC.

CMC Decision on manufacturers' details on labelling

The Danish Medicines Agency informs that Manufacturers of medical devices are to comply with the EU Central Management Committee (CMC) decision no. 3 on manufacturer address details on labelling by 1. September 2012.