Until now, Switzerland and the EU have relied on a specific chapter of the Mutual Recognition Agreement (MRA) for trade in medical devices. Without an updated MRA having been produced by the MDR deadline last week (26th May 2021), Switzerland has now become a third country for the purposes of the implementation of the MDR. Our CEO Jörg Dogwiler delves deeper into how this will impact medical devices trade between Switzerland and the European Union…
The MRA is one of the key agreements between the EU and Switzerland, facilitating bilateral trade in key sectors such as machinery, motor vehicles and medical devices.
Switzerland has been participating in the European Union internal medical devices market through a specific chapter of the EU-Switzerland MRA which has previously recognised conformity assessment certificates between the EU and Switzerland based on equivalent regulations. The agreement has traditionally facilitated seamless trade of medical devices between the two parties.
This MRA falls under the scope of the new EU-Switzerland Institutional Framework Agreement (InstA) which has been in negotiation between the EU and Switzerland since 2014. But the EU has now stated that in the absence of a deal regarding the implementation of the Institutional Framework Agreement (InstA), a full update of the MRA (including the medical devices chapter) cannot be considered.
Following the Swiss Federal Council’s cessation of InstA negotiations on 26 May 2021, and until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices falling under the new Medical Devices Regulation, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, cease to apply.
As such, the following consequences should be noted by economic stakeholders for medical devices as declared in the position paper by the European Commission (dated 26 May 2021):
Trade of Medical Devices from Switzerland to the EU
Swiss manufacturers looking to market their new medical device in the EU will be treated as any other third country manufacturer intending to place their device on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU. This unilateral determination by the EU is disputed by Switzerland, as valid certificates issued under the existing MRA should arguably be given a transition period. This point represents a regulatory uncertainty and is currently being clarified between the EU and Switzerland.
For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU.
Trade of Medical Devices from the EU to Switzerland
On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market.
This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA medical device manufacturers.
The transitional provisions also affect registration and reporting obligations, in particular (owing to the lack of access to EUDAMED3), economic operators including manufacturers, importers and authorised representatives must register with Swissmedic to obtain a unique identification number (“Swiss Single Registration Number” CHRN).
The definition of new requirements for medical devices trade between the EU and Switzerland based on the unsolved MRA situation is a complicated and uncertain regulatory issue. We will continue to monitor the evolving situation and keep you informed of any new updates. In the meantime, should you have any questions regarding this area please do get in touch – we are ready and happy to help.