Germany: Regulation on unannounced audits

The European Commission issued a Recommendation on unannounced audits in September 2013, which have raised many questions and differences in notified bodies’ approach and uncertainty by the medical device manufacturers resulting from it. In order to ensure consistency of approach, the German Ministry of Health (BMG), state authorities and the ZLG (Central Authority of the states for Health Protection with regard to Medicinal Products and Medical Devices) have stated their joint position as an announcement.

The announcement, which was issued in June 16, 2016, will be also introduced to the relevant European Committees.

The announcement is available under Publication of the Federal Ministry of Health on unannounced audits.