(08/2022) Erhard Fichtner, Chairman of the Board of the German Health Alliance (gha)
The EU Medical Devices Regulation MDR is the subject of intensive discussions in the industry. The MDR poses numerous challenges and risks, especially for the export-driven and medium-sized German medtech industry. Improvements at EU level are necessary.
The Medical Device Regulation ( MDR ), which has been in force since May 2021, has been redesigned to create uniform European law for medical devices. It defines the approval criteria according to which products can be placed on the market. Patient safety is a trigger for the new regulation, especially after the silicone implant scandal in 2010, but the desire for an optimally regulated internal market for medical devices certainly preceded this.
However, this new MDR poses a threat to the entire medtech industry in Germany. A large part of these often medium-sized companies is represented in the German Health Alliance (GHA), so we have an up-to-date and precise view of the situation.
The GHA and other industry associations such as Spectaris, BVMed or ZVEI call for substantial and realizable improvements in the new MDR.
The dangers of the MDR and their consequencesThe MDR directive significantly limits the chances of German medtech manufacturers in international competition. The massive effort required to comply with the new regulations contradicts the regulation's effective entry into force in 2024.
This primarily affects small and medium-sized companies, which quickly reach their capacity limits. In fact, it is not possible to recertify all products before the deadline set in 2024. An unfortunate side effect: Rapid innovations in particular are prevented in this way.
Politicians must create a clear interim solution or change here, because more than 66 percent of the medical devices in the German medtech industry are approved for export.
Relevant authorities, certification bodies ("Notified Bodies") and the entire transition chain should be set up and expanded in such a way that the MDR specifications and deadlines can be implemented. So far this has not happened. Due in particular to the scarce capacities available on the certification side, these medical technology volumes cannot go through the necessary approval process.
As part of our commitment within the GHA, we also want to ensure that existing products and Nisc
