One topic continues to cause a big stir...

Another topic also caused great unrest in the industry: On May 26, 2021, the new European Medical Device Regulation (MDR) and the new Regulation on In-Vitro Diagnostic Medical Devices (IVDR) came into force. As the trade magazine Devicemed points out in a long review article, companies are ready, but also clearly under pressure. According to a survey from the software company Climedo Health, 81% of the 115 companies surveyed from across Europe still find the MDR very challenging. The biggest hurdles are presented by an increase in the resources and costs needed, a lack of clarity and the requisite clinical testing. 31% estimate that MDR will add costs of 5 – 10% of their annual revenue and 13 percent even believe it will be over 10% of their revenue.


The companies' dissatisfaction with the powers that be in Brussels is also mounting in other aspects: 75% want clearer specifications from the EU Commission, 50% want more specialist support and 30% want training or information events. "The survey results show that the EU MDR continues to be very challenging, expensive and time-consuming for companies", states Veronika Schweighart, COO at Climedo Health. The IVDR also increases effort and costs for companies. Along with new products, all approved products which are already available on the market need to undergo recertification in accordance with the regulation. In addition, the "notified bodies" must undergo a new designation procedure, which has not yet been finalized. Furthermore, the IVDR covers a broader scope than the previous directive and entails higher and also new requirements for companies and monitoring bodies in many areas. This will provide plenty of topics for discussion at COMPAMED 2021.

The Medical Device Regulation: as tough as cold fusion?

The COMPAMED SUPPLIERS' FORUM (in Hall 14) also picks up on this topic in its series of talks. "Often, when dealing with the MDR or the IVDR, one has the impression that we're working on cold fusion or rocket science. The basics for all of the points stated above are lacking. I cannot yet say which of the three topics will be resolved first, but at the very least, we can all be better informed on the MDR and IVDR. There were many difficult aspects, but also well-solved issues – complicated guidance, which is a contradiction in itself, and clever solutions", summarizes Stefan Bolleininger, CEO of the consulting firm be-on-quality. His presentation (on November 17) will show concrete examples from everyday consulting work and solution options for various problem scenarios. This concerns, for example, the handling of non-harmonized standards or what is considered to be state of the art.

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