Current assessment of medical device manufacturers on the effects of the EU Medical Device Regulation (MDR) Dec. 2023

The results of the nationwide joint industry survey current assessment of medical device manufacturers on the effects of the EU Medical Device Regulation (MDR) conducted by the German Chamber of Industry and Commerce (DIHK), Medical Mountains GmbH and the industry association SPECTARIS, in which around 400 German medical technology manufacturers took part.

New MDR transitional provisions adopted and all problems solved? Unfortunately not.

The industry’s assessment of the European Medical device Regulation (MDR) is sobering: the new legal framework means that many medical devices are already being withdrawn from the EU market and many more will disappear in the coming years. Numerous unresolved problems are weakening Germany and the EU as centres of healthcare and innovation. These are the findings of the nationwide joint industry survey current assessment of medical device manufacturers on the effects of the EU Medical Device Regulation (MDR) conducted by the German Chamber of Industry and Commerce (DIHK), Medical Mountains GmbH and the industry association SPECTARIS, in which around 400 German medical technology manufacturers took part. We would like to summarise three key statements in advance:

  • 97 per cent of the companies participating in the survey continue to have problems implementing the MDR. The drivers are the high costs, lengthy procedures and bureaucracy.
  • In more than one in two product portfolios, individual products, sometimes entire product lines and complete product ranges are being withdrawn from the market. In almost 20 per cent of cases, there are no equivalent alternatives on the market.
  • Three quarters of companies are experiencing negative effects on their innovation activities. Almost one in five companies are switching their medical technology innovations to other markets, mostly to the USA.

The study contains much more relevant data.

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