Hans-Peter Bursig of the German Electrical and Electronic Manufacturers´ Association (ZVEI) describes the problems, illustrates the completed steps and reveals the role that Brexit plays in this setting.
Mr. Bursig, the MDR was published in 2017 and aims to improve patient safety. That’s actually a good thing. Why does it face such harsh criticism from medical device companies and their suppliers?
Hans-Peter Bursig: The new regulation does not improve the safety level from the perspective of medical device companies. Medical devices are already very reliable, effective and safe. Now there are readjustments at several points, including added regulatory controls and inspection measures, as well as very precise specifications and instructions on how to perform certain processes. It increases safety as a result of more effort on the part of the manufacturers and the Notified Bodies. Added safety is always a good thing. However, the criticism refers to the fact that all of these measures will have to be taken for all devices during a very brief transition period. This also includes legacy devices that did not require a safety corrective action in the past ten years. This calls for an extensive effort of companies, which can only be managed with considerable time and expenditure during the remaining time. As a result, many manufacturers seriously consider a product portfolio reduction.
This would especially affect niche products that cater to children for example. Do you think this might really happen?
Bursig: We believe that this will very likely be the case. We surveyed our members, which include large enterprises, as well as small and medium-sized medical device companies. On average, between five and ten percent of the devices these companies currently have in their portfolio will likely disappear from the marketplace. This will initially affect many product variants, such as an ECG device that comes in seven different variations. A company then might only offer five variations of this device in the future. Many variants will no longer be available on the market because manufacturers will carefully review whether the considerable effort for the new conformity assessment and ongoing documentation update requirements pays off for them. And this might also affect devices that were specifically designed for children.
Is it possible that devices might not be taken out of the product portfolio but instead get relocated to the FDA sector?
Bursig: We don’t think this will happen. Needless to say, manufacturers can always choose to no longer market a product in Europe and take it to markets outside the EU. However, manufacturers always need to consider whether this is a step that pays off in the end. After all, the company subsequently manufactures a device for the U.S. market, which is not approved for the European market. That’s why I don’t expect this to happen on a large scale.