Tuttlingen/Stuttgart/Berlin – MedicalMountains GmbH and the industry association SPECTARIS regard the appeal of the Baden-Württemberg state government to Berlin and Brussels to urgently set the course for the implementation of the EU-MDR as an "important step" and "a clear signal to act now". to do. Both industry organizations were present at the expert hearing of the state government in advance and see many of their concerns addressed.
Prime Minister Winfrid Kretschmann, Economics Minister Dr. Nicole Hoffmeister-Kraut and Social Affairs Minister Manne Lucha to the German Federal Government and the EU Commission. The signatories emphasize that the EU MDR itself will be adhered to. However, "where some requirements cannot be met by the companies in the given time through no fault of their own, or lead to an unacceptable burden on the financial and human resources of the companies", they advocate relief and support. Among other things, the lack of functionality of the EUDAMED database, the certification backlog due to too few notified bodies under EU-MDR, open questions of interpretation of the regulation and the handling of existing products are mentioned.
MedicalMountains GmbH and SPECTARIS were involved in the expert hearing with Prime Minister Winfried Kretschmann. "On the one hand, it was and is important to us to present the current situation in the industry with examples," says MedicalMountains Managing Director Julia Steckeler, "and on the other hand, not just to show problems, but realistic and pragmatic solutions." Some of these points were already in the September last year, when Minister President Winfried Kretschmann visited the MedicalMountains and dealt with the industry's concerns.
"Baden-Württemberg is the number one medical technology state," remembers Julia Steckeler. Therefore, the federal state has a leading role to point out the deficiencies in the MDR system and to bring about an improvement - a clear signal to those responsible in Berlin and Brussels to act now. "Too many medical technology companies are faced with unacceptable challenges through no fault of their own," emphasizes Corinna Mutter, Head of Regulatory Affairs and EU Affairs at SPECTARIS. "The state government's paper contains many good recommendations for action on how to relieve the system and provide support." Without such measures, not only will the industry be hit hard economically, but above all the security of care for patients will be endangered. This message must reach society. "We will follow the further steps of the state government and of course continue to advocate a practicable, functioning EU-MDR in talks," say Julia Steckeler and Corinna Mutter together.
