Germany (MDR): Every third medical technology company fears for its existence.

Medical care with innovative medical products is increasingly endangered in Germany. This is the result of a recent survey by the German Chambers of Industry and Commerce (DIHK) and the Spectaris industry association. According to the survey, almost 80 percent of medical technology companies expect to encounter considerable difficulties in bringing innovative products to market in the future.
The reason for this is the introduction timetable for the new EU regulation on medical devices (MDR), which came into force at the end of May 2017.

“We see the danger that many smaller manufacturers in particular will have problems with market access for their products. This jeopardizes the existence of these companies and thus slows down the supply of patients with innovative medical technology” (Dercks, managing director DIHK).

Overall, around half of the companies surveyed wanted to reduce their product lines. Approximately one third of the companies that have to classify their products higher according to the MDR are already planning to discontinue products. Many products could therefore no longer be available for health care at the start of the MDR in May 2020.

The study also shows that the uncertainty among companies is enormous. Hence, three quarters of the companies surveyed rate the unclear legal situation surrounding MDR as a major or very major problem.

In order to help companies, politicians should therefore implement the following measures:

  • More practicable transition phase
  • Protection of existing products for proven old products
  • Special regulations as in the USA for niche products
Author(s)Source
editor: Peter ReinhardtDeviceMed, 13.02.19
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