Switzerland will soon accept FDA 510(k) cleared medical devices. Perhaps the EU MDR pathway is too onerous for some companies?

On the 28th of November 2022, the Swiss Parliament National Council voted to allow Switzerland to accept the use of medical devices with FDA clearance. This change to the national laws will put an end to rules that stipulate that healthcare providers and patients in Switzerland only have access to EU-certified medical devices.

The motion was first introduced by Liberal Councillor Damian Müller back in May 2020. He reasoned that allowing FDA-cleared devices was needed to give more room for manoeuvre in the procurement of medical devices for the Swiss population. This was needed because the onerous requirements of the EU Medical Device Regulation (MDR), as well as Switzerland’s legal requirements for medical devices created too many blockages for MedTech manufacturers in the Swiss market.

By the end of May 2021, the revised EU MDR came into full effect which requires all medical devices – even those that were already approved – to be recertified in order to comply. There are various challenges associated with the application of the new MDR, such as a lack of enough notified bodies and an increase in technical, administrative and clinical research requirements. As a result of these hurdles, medical device manufacturers have reduced their product portfolios or chose to market their products only in the US – impacting the supply of medical devices across Europe.

Additionally, Swiss law specifies that medical devices manufactured abroad must fulfil requirements beyond the new MDR. When the transitional period of the MDR ends, at the latest in 2024, it is expected that the collective effect of these requirements will pose a threat to the treatment of Swiss patients and the supply of medical devices in the country.

These regulatory hurdles led increasing numbers of start-ups and SMEs in Switzerland and across Europe to choose to market products at first under the 510(k) pathway in the US, often conducting post-market research there to support MDR applications as the evidence requirements to obtain clearance in the US differ from those needed in Europe.

As such, state-of-the-art Swiss products would only be available to countries outside Switzerland. Based on these concerns, the Swiss Parliament instructed the Swiss Federal Council to change the laws so that FDA-regulated medical devices could also be available on the Swiss market.

The scope of the changes in the Swiss regulations still needs to be clarified. However, once these changes come into effect, Switzerland may become the most viable country in Europe to conduct post-market medical device research. While the development of MedTech in the EU will still need to conform to the MDR, regulations for gaining access to medical devices in the Swiss market may become far less cumbersome.

Working with a CRO that understands the EU MDR and its impact on research is important. At Clinicology, we advise our clients on the most suitable locations for medical device trials as part of our high quality services to ensure your trial reaches its goals. To find out how we can help you, please contact info@clinicology.com or call +44 (0) 1483 977 777.