On the safe side with regard to the MDR
GBA Medical Device Services has already been recognized by the ZLG according to MDR – as one of the first laboratories in Germany. The tests performed by Medical Device Services always fulfill current standards and guidelines, if available already based on the MDR. Through active participation in all relevant standards and expert committees bodies this is guaranteed even for the transition period as well. The MDR also confirms the strategies applied by Medical Device Services since years.
Nevertheless, inter alia we recommend consideration of the more precise rules of the MDR (see annex II) for integration of the test reports into technical documentation as well as reference of our recent certificates.