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MDR Transition Period – All Clear at Half Time?

Slowly but surely, the end of the transition period for the EU Medical Device Regulation (MDR) of 25 May 2020 is approaching. In the meantime, half of the three-year transition period has elapsed and it is foreseeable that implementation of the MDR in companies in the medical device industry will only progress slowly and that pressure will increase.

This is underlined by the results of a recent survey conducted by RAPS and KPMG. Many of the medical device manufacturers surveyed lack long-term planning to meet the requirements of the new MDR. Only 22% of the respondents confirm a comprehensive understanding and strategy for the MDR impact; 41% have little to no knowledge of the regulations. It is very critical that almost 80% of the respondents currently lack the necessary knowledge and understanding of MDR. Nevertheless, technical experts and the industry associations recommend continuing to work at full speed on the rapid implementation of the MDR requirements. All stakeholders are waiting for detailed information that will make the implementation of the MDR livable. In the meantime, the European Commission has issued a step-by-step guide and a fact sheet for the implementation of the Medical Devices Ordinance. In 2018, the MDCG (Medical Device Coordination Group) also published the first MDR guidelines. But there are still too many ambiguities, such as the term “sufficient clinical data”.

The 4th Spring update Medical Device Conference of TÜV Rheinland Akademie addresses questions and problems in the interpretation and implementation of Medical Device Regulation. The conference also provides a platform for information and exchange on current focal topics for medical device manufacturers. The conference program and registration information can be found at:

https://akademie.tuv.com/shop/product/4-spring-update-medizinproduktekonferenz-2019-5865