At the end of September 2013, DEKRA’s designation as a Notified Body was independently assessed as part of the EC initiative to further improve safety within the medical device industry. We are delighted to confirm that we passed the audit successfully.
The audit was the result of a proposal dating back to early 2012, when European Commissioner Dalli wrote to Member States of the European Union asking for their co-operation in tightening controls, within the existing legal framework, in order to provide a better guarantee of the safety of medical technology, especially high-risk devices. One of the proposed actions was to verify the designations of Notified Bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence.
Hence, our designations were assessed in late September by a joint audit team which comprised the IgZ (Inspection of healthcare in The Netherlands), two auditors from two other Member States and two inspectors from the Food and Veterinary office who were assigned by the European Commission to witness the audit.
We received positive feedback from the audit team on our processes and competence, and there were only a minimum number of minor non-conformities, which we have since addressed. Therefore, even within this framework of tighter controls, you can continue to rely on DEKRA’s expertise in certifying your (high risk) medical devices and equipment.