Medical Devices

Directive becomes regulation Tightening European controls on Medical Devices  Acting carefully in the market is nowhere more important than in healthcare. It is always directly about quality of life and even life and death. As governments want to leave more to the market, legislation and regulations become more important. It is about safety, performance, does the product do what is promised, and clinical evidence, what are the side effects? The FHI Medical Technology sector recently organized a well-attended symposium on the European MDR, Medical Devices Regulation, legislation that will come into effect in the middle of this year. 'The biggest game changer in EU since decades for the medical devices industry', said the lawyer Erik Vollebregt it in his presentation. Erik is affiliated with Axon Science Based Lawyers as a lawyer, specialized in life science. In a conversation with him and two suppliers of medical devices, it becomes clear that there is indeed a serious impact on the industry. The reference interlocutors are Jan Harks, clinical expert at home care supplier and service provider Vivisol and Bass Dirkson, experienced entrepreneur in the healthcare market and CEO of start-up Wind Tales. That company is launching a revolutionary medical 'serious gaming' product to therapeutically help and monitor people with breathing problems. “People who have difficulty maintaining their boring exercises at home will do their exercises longer, better and with pleasure thanks to our game.” “We have had European guidelines for medical devices since 1990, via the CE marking. What I have to emphasize to companies every time is that there is now a supernova in regulation. We are moving from three partially harmonizing directives to a package of two directly applicable regulations. And that is just the beginning because this will be further elaborated with detailed further European implementation legislation.” Vollebregt speaks emphatically. What actually changes? Erik Vollebregt knows the whole story. “Scandals such as the breast implant scandal revealed that there is insufficient prior testing of compliance with regulations. In 2012, the European Commission started taking actions to raise the level of 'notified bodies'. Since then, a quarter of them have been exposed. Now the 50 to 60 that remain have to reapply for accreditation, which will probably mean another half will drop out. In addition, manufacturers are required to carry out an additional clinical evaluation at European level for certain high-risk devices, in addition to the notified body procedure, as part of the requirements for the mandatory technical file. A risk plan will become mandatory and more structured post-market surveillance must be done.” Post-market surveillance in particular is becoming a lot more difficult. “There will be a European Eudamed database in which all information must be entered. Ultimately, every device, up to and including the smallest scalpel, will receive a UDI, Unique Device Identifier. Everything in the value chain must become extremely transparent, including the supervisory side. There will be a new European regime for clinical trials of medical devices.” It is therefore clear that suppliers and distributors of medical devices must play an active role. How will the regulations compare with those in the US with the FDA? According to Erik, that depends on who you ask the question to. “The FDA believes that Europe is lagging behind and the EU believes that an authorization procedure is in place in the US that adds nothing except costs, unnecessary clinical research and extra time. The US has a more pre-market approach and Europe more of a post-market approach. That is why the Americans like to say that Europe treats its entire population as guinea pigs, guinea pigs. However, research shows that there are no more incidents with CE marked medical devices than with FDA approved medical devices.” What are the consequences for medical technology companies? Jan Harks sees some things coming his way. “We have to do all kinds of checks and reports and are given more responsibility. Everything we purchase must comply with the new regulation. I am afraid that certain smaller suppliers will not be able to achieve that.” Bas addresses his colleague directly. “You, Jan, will be responsible for the post-market surveillance of your suppliers to your customers.” Jan knows that. “We have to try to solve this mainly through automation, but it certainly increases costs. Passing on these costs will be difficult given the policy of health insurers.” Will this have an effect on the extent to which innovations reach the healthcare market? Jan Harks and Bas Dirkson think so. “I support the idea of the regulation,” says Bas. “I want to be able to provide patients with reproducible quality and to be able to fulfill claims. I am convinced that you can translate more far-reaching claims into a better price. But the financing requirement when introducing an innovation will increase. Financiers will have to get used to that. In principle, harmonized registration for all EU countries should lead to faster market penetration. But the path to introduction is getting longer and that has an effect on the pace of innovation.” Erik, the lawyer, adds nuance: “Companies are quick to say that their innovative power is being undermined. It indeed takes time and money to do new certifications. But I also see companies sometimes cutting corners in a scandalous way. Clinical and Performance Evaluations are sometimes really far below par. There is a lot of tinkering with software and companies have a decidedly non-compliance-oriented attitude. The attitude of 'if it has to be compliant then it is no longer lucrative' is of course not possible.” Bas notes that the effort for start-ups is increasing. “That must be pre-financed.” “Of course we are not talking about flashlight apps or something that can make you rich from your attic room. If you claim clinical performance, you must be able to substantiate it properly,” says Erik. What matters is; producers, suppliers, 'watch your eyes', be prepared for the new legislation. It is now coming quickly: entry into force in June this year, with a transition period of three years.