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Medical Device Regulation

Medical Device Regulation delayed to 2021

The replacement of the Medical Device Directive (MDD) with the Medical Device Regulation (MDR) has been delayed to 26 May, 2021.

This delay is due to the COVID-19 pandemic, with the EU wanting medical device manufacturers to prioritize the production of medical devices which will help fight coronavirus. Implementing MDR regulations would require medical device manufacturers to make significant safety changes, thus shifting the focus away from fighting the pandemic.

Given the magnitude of the changes in the new MDR regulation, we urge manufacturers to not postpone updating their quality standards. This delay gives you the opportunity to implement the required changes before the regulation takes effect. These changes include:

  • The recertification of existing products, ensuring compliance with MDR standards
  • A new standard for technical documentation and labelling
  • The providing of detailed clinical data as evidence that the new safety standards are being met
  • Incidents that did not result in death must be reported within 15 days rather than the previous 30 days.

To help you use the time between now and May 26, 2021 wisely, the Tentamus Group has developed a detailed test program which covers the entire spectrum of chemical characterization and in-vitro testing according to DIN ISO 10993.

Details on the services we offer can be viewed in our previous article on this subject here.

Get your medical device MDR ready now. We assist you by offering attractive biocompatibility testing packages in 2020.

If you have any further questions, our experts will be happy to help you:

Dr. Wolfgang Rudy
CSO Tentamedix GmbH
+49 (0) 721 9415213

Dr. Dominik Herzog
Managing Director Tentamedix GmbH
+49 721 957 919 596

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