Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR

A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under the EU Medical Device Regulation (MDR).

The National Center for the Certification of Medical Devices (CNCps) is a public group attached to the Spanish medicines regulator AEMPS, setting it apart from the private, commercial enterprises that are active in other countries. AEMPS said CNCps has the experience and knowledge of its certification area, which was the only Spanish notified body designated under the old directives…