Tuttlingen – MedicalMountains GmbH and Johner Institute are jointly launching a survey: If you, as a manufacturer or notified body, have the impression that the MDCG, the BMG, the BfArM, the ZLG, other authorities or the notified bodies themselves are aware of the current (regulatory) problems tighten up, then let us know! The answers help to create evidence and thus clarity.
On April 23rd and 24th, MedicalMountains GmbH organized the symposium "International Approval of Medical Devices". The ZLG, the FDA and also the Johner Institute were there. During the course of the event, the participating medical device manufacturers presented the ZLG with a long list of problems that they or their notified bodies suspected that the ZLG, other authorities or the MDCG were partly responsible. Requirements would be made that go beyond those of the MDR. ZLG Director Dr. Rainer Edelhäuser was able to refute the (indirect) allegations. He promised that a statement would be made on specific facts that had been stated.
The conversation channel is open. We want to use this together with the Johner Institute and proceed as follows:
- You use this link (anonymously if you like) to describe the problems that you suspect are related to the MDCG, the BMG, the BfArM, the ZLG, other authorities or notified bodies.
- We cluster this feedback.
- We pass this clustered feedback on to the responsible persons and hope for their opinion.
- We, together with the Johner Institute, publish both the clustered feedback and a rating based on responses we receive.
Please help to create evidence and thus clarity. Please describe your assessment on this page. It takes a few minutes, but it's worth your time - just as you helped us to shake up politics and initiate improvements in the joint survey by MedicalMountains with DIHK and SPECTARIS at the beginning of 2022.
