New nomenclature for incidents with medical devices

New nomenclature for incidents with medical devices

Belgium From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical device to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes. The...

New Medical Device Directive

EU Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official...