Preparing for unannounced medical device inspections in the EU - are you ready?

摘要

The long expected European Commission recommendation on audits and assessments performed by notified bodies in the field of medical devices was published on 24 September, together with the commission implementing regulation on designation of notified bodies.Both documents can be seen as output of the immediate action plan initiated by former EU health commissioner John Dalli following the PIP breast implant affair Consequently they will have a short transition period, of only a few months. Whilst the recommendation includes detailed expectations on evaluation of technical files and design dossiers, regular conformity assessment audits as well as situations around own brand labeling, the most critical element of the document is seen as expected unannounced visits, that are to be added to the existing audit structure. Unannounced visits will be essentially different from the well planned pre-scheduled audits.A commission recommendation is a new tool in the EU medical device world. Although it is gently phrased as a request to member states to use the details in identifying their expectations on notified bodies, effectively it can be seen as soft legislation, with a significant legal status. At this stage most member states have already confirmed they will endorse the document and follow it as part of their duty to oversee the work of their notified bodies.Moreover; in support of that effort and, as requested by individual member states, a number of unannounced visits have been performed over the past year.