EU system losing its competitive edge
Swiss Medtech’s MDR conference in Bern – which for years has attracted over 400 medtech industry representatives from Switzerland and abroad – turns its focus this year to the regulation of medical devices. What may seem uninteresting to the general public is highly relevant for the industry and the healthcare system as a whole.
Five years after entering into force, the problems associated with the new European Medical Device Regulation (MDR) are beginning to show. One representative survey published in June 2022 by the European umbrella organisation MedTech Europe reveals: Of the more than 500,000 medical devices registered under the previous directives (MDD), only 15 percent have been recertified as required by the new regulation (MDR). Certificates have not been issued for the remaining 85 percent as certification bodies (Notified Bodies) are unable to meet demand.
EU member Germany wants to counteract regulatory deficits
The EU is attempting to resolve the situation by recommending specific points for action. Late August 2022, the European Medical Device Coordination Group (MDCG) published a document outlining measures to improve MDR implementation. Dr Marc-Pierre Möll, CEO of the German medical technology association BVMed and guest speaker is convinced that «The paper contains valuable initiatives, but not enough to guarantee uninterrupted patient care in Europe. We need substantial pragmatic solutions to ensure the successful implementation of the MDR.»
According to the BVMed CEO, capacity bottlenecks affecting MDR implementation not only jeopardise the provision of patient care, but also curb innovation within the industry. This in turn will reduce the appeal of Europe as a medtech business location. «The EU system is clearly losing its competitive edge when compared to the FDA,» says Möll. The figures speak for themselves: 50 percent of companies surveyed across Europe today prioritise FDA approval over MDR marketability. «This shift throws us back years in terms of quality of care».
The United Kingdom opts for its own regulations
Phil Brown from the Association of the British Healthcare Industry (ABHI) provided information on post-Brexit developments to date. Since leaving the EU in February 2020, all medical devices placed on the market in the UK must now be registered with the British Medicines and Healthcare products Regulatory Agency (MHRA), and carry a UKCA label from 1 July 2023. As a non-EU member, the UK is relying on its own regulations. Phil Brown emphasises: «The drafting of regulations is based on the premise that the UK should become an attractive centre for medtech activities and research. We are aligning ourselves globally and want to learn from the best systems. In addition to the economic aspects, the aim is to secure supply, research, and entrepreneurship for our country».
What can Switzerland learn from the current situation?
«In light of the uncertainty and restrictions associated with third-country status and the MDR, Switzerland should accept medical devices with FDA approval (in addition to medical products bearing an EU certificate) in order to safeguard the supply of its own population», says Swiss Medtech Director Peter Biedermann. Two motions demanding precisely this from the Federal Council are currently being considered by parliament. One of the two is currently under discussion by the competent national health commission. «We hope for forward-looking decisions from the politicians». Swiss Medtech is strongly advocating for an update to the MRA which will preserve direct access to the EU single market. The association will continue to work with unwavering commitment with partners and alliances to ensure that Switzerland’s relationship with the EU regains a solid and lasting foundation.
Swiss Medtech represents more than 750 members in its role as industry association for Swiss medical technology. With 67,500 employees and a contribution of 11.5% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.