BVMed, the German trade body for MedTech, has been quite vocal on the subject of the new EU Medical Device Regulation (MDR) lately. Readers of On The Pulse may have come across our recent article on the joint initiative between BVMed and SNITEM (the French trade body for MedTech), which aims to lobby the European Commission into taking radical steps to soften the European MedTech industry's transition to the MDR in order to prevent a "collapse" of patient care. Strong stuff!
BVMed has now published some fascinating infographics on the MDR, which show some disturbing trends and helps to explain why BVMed is pushing so hard for more intervention from the European Commission. The infographics and accompanying text on the BVMed website are currently only available in German, but the following passages attempt to summarise the key points.
One infographic shows that the number of Notified Bodies (certification organisations that are tasked with assessing whether medical devices conform with the regulatory framework and can be placed on the market in the EU) has been in decline for a very long time. From a high of 80 in 2012, the number fell to 58 in 2020. When the MDR Date of Application arrived in the following year and Notified Bodies under the previous regulatory framework became defunct, there were only 20 Notified Bodies designated under the MDR ready to take up the task. Even now, there are only 28. Most concerning of all? Only 56 organisations have applied to become Notified Bodies under the MDR. Even if every application were approved tomorrow, there would still be two fewer Notified Bodies in existence today than there were in 2020 - and 24 fewer than there were in 2012.
Of course, it's not all about the number of Notified Bodies in existence. It's about the total capacity which Notified Bodies have to perform their essential regulatory functions. That is exactly what another BVMed infographic tries to estimate by looking at the number of staff working at Notified Bodies today - and it paints a bleak picture. Looking only at the essential personnel who contribute to Notified Bodies' capacity to perform their essential regulatory functions, there are 20% fewer such personnel working at Notified Bodies today than there were in 2020. The same infographic estimates that the number of Notified Body essential personnel needs to almost quadruple in order to meet the increased regulatory demands of the MDR: more products requiring assessment, more strenuous assessment procedures, and more products in higher risk classifications.
A third infographic makes the point that the bureaucracy entailed by the MDR is putting the brakes on innovation. BVMed claims this is partly because at least 450,000 existing medical devices are having to undergo a new assessment under the MDR in order to simply remain on the market, taking away time and resources from new and innovative medical devices trying to get to market for the first time. BVMed also warns that it is concerned about an exodus of businesses leaving Germany as a result of the bureaucratic demands of the MDR.
So far, we have only seen limited evidence of a small number of MedTech companies choosing to take their products off the European market rather than adapt to the MDR, and these have tended not to be innovator companies. However, with the Date of Application of the In Vitro Diagnostic Medical Device Regulation coming later this month, which will increase the burden on MedTech companies and Notified Bodies even further, we may see that trickle start to become a flow.
With less than two weeks to go until the Date of Application of the IVDR on 26 May 2022, why not take a look at our 'Spotlight on IVDR' article series where we take a closer look at the possible impact of this revolutionary piece of legislation.
Deutschland droht wegen der MDR-Überbürokratisierung ein Innovations-Stau und - wie eine Umfrage der Boston Consulting Group gezeigt hat - auch eine Auswanderung vieler Deutscher Unternehmen ins Ausland.
("The over-bureaucratisation of the MDR threatens to clog innovation in Germany and - as a survey from the Boston Consulting Group has shown - also threatens an exodus of many German businesses to other countries.")