Trade barriers ruffle feathers of Swiss and EU MedTech Manufacturers with potentially dire consequences for Patients
Until May 25, 2021, any MedTech goods approved for sale in Switzerland and the EU could be marketed in both markets. Under the terms of the bilateral Mutual Recognition Agreement (MRA), the EU and Switzerland agree that medical devices manufactured by one party must uphold the technical standards of the other party. This removes trade barriers and facilitates manufacturers to offer their products through mutual market access. Switzerland updated its own medical device rules in response to revisions to EU-MDR. The parties could not achieve an agreement and sign off on the prerequisite Institutional Framework Agreement and amend the MRA before May 26 2021, when the EUMDR came into force. The MRA no longer applies, effectively downgrading Swiss Medtech to “3rd nation” status.
These four scenarios may precede the perfect storm—the goliath task of implementing the EUMDR. Trade barriers for medical device manufacturers will cost the Swiss Medtech industry an initial 114 million and then 75 million annually, as predicted by SwissMedtech (https://www.swissmedtech.ch/en/news/swiss-medtech-downgraded-third-country-status-today). Reduced patient access to treatment: market access is no longer guaranteed for medical equipment, as imports face rising administrative and financial constraints. Analysts are concerned that overseas manufacturers will be deterred from supplying their products to Switzerland. Finally, the Corona pandemic, in which medical technology underpins national and regional healthcare system capability and response.
Swiss MedTech firms are now required to appoint an Authorized Representative to market medical devices in the EU. Equally, the Swiss Medical Device Ordinance (MedDO) requires manufacturers based outside of Switzerland to appoint an Authorized Representative based in Switzerland to place a product on the Swiss market. The Authorized Representative assumes tasks on behalf of the manufacturer – which covers re-relabelling medical devices, generating associated technical documentation, liaising with authorities and product liability, amongst other areas.
Hospitals, clinics, laboratories, and other healthcare service providers that have relied on the supply of medical devices or in-vitro medical devices from the European Union in the past may look to import these products from further afield, and the means of doing so must be rapidly addressed. Interruptions to the supply of essential medical devices, including ventilators and medical masks, must be minimized. In the meantime, businesses manufacturing medical devices aimed at the EU or the Swiss market will have to assess their business strategy in terms of supply chain, Authorized Representative, tax and VAT, having the correct set of legal agreements in place, and level of regulatory compliance to identify the necessary modifications needed to meet the new Swiss and EU industry regulations.
Author: Lara Bartlett, Digital Content Creator, KVALITO
KVALITO is a strategic partner and global quality and compliance services and network for regulated industries. Our specialized consultants can support you to successfully navigate the regulatory environment applying to the Medical Device and Life Science industry as a whole. To learn more about our services, feel free to send us an email at firstname.lastname@example.org