Brexit has dominated the political headlines since the 2016 referendum, and finally came to fruition on 31 January 2020, with the UK bowing out of the European Union. The major difficulties and uncertainties have been well-documented, not least in the medical devices sector.

Medical device manufacturers can’t rest easy knowing they have plans for the impending Medical Device Regulations (MDR)[1] and Brexit, as another spanner may be in the works – ‘Swexit’.

What is ‘Swexit’?

Although Switzerland is not a member of the EU,  the mutual recognition agreement (MRA) harmonises laws in each jurisdiction and for virtually all purposes creates a single market for medical devices. The MRA seeks to eliminate barriers to trade with regards to medical devices, et al., by harmonising standards and requiring a single conformity assessment for both territories. The European Commission defines MRAs as:

“Mutual Recognition Agreements (MRAs) promote trade in goods between the European Union and third countries and facilitate market access. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment.”[2]

There is, however, a growing concern that the MRA will no longer apply to medical devices after 26 May 2020. The MRA would ordinarily be updated to include the MDR to continue the harmonised approach. However, this appears unlikely in the current political climate as a result of broader considerations, namely stalled negotiations between the EU and Switzerland as regards to their future relationship.

The Swiss medical device industry body, Swiss MedTech, issued a warning last week that Swiss medical device manufacturers should prepare for a “realistic worst case scenario”.[3]

This risk has been in the pipeline for a long time. Swiss Medtech have warned of the possibility of ‘Swexit’ and its impact since April 2019.[4] The uncertainty arises, because there is legal ambiguity between the EU and Switzerland, with regards to the interpretation of the MRA.

The impact of ‘Swexit’

Swiss Medtech warned that the “worst case” scenario is now a real prospect, such that Swiss manufacturers will have to meet third country requirements for all medical devices (whether legacy Medical Device Directive-compliant devices or MDR-compliant devices) from 26 May 2020.

Among other things, if ‘Swexit’ occurs, then in order to sell medical devices into the EU after 26 May 2020 it is arguable that:

• a medical device manufacturer established in Switzerland should designate an EU authorized representative (and a Person Responsible for Regulatory Compliance)[5] and amend labelling accordingly;
• medical devices manufactured (or refurbished) in Switzerland will need to be “imported” into the Union and the labelling amended accordingly; and
• medical devices CE Marked by a Swiss Notified Body may not be placed on the market in the EU from 26 May 2020.

This is a potentially critical issue, that could affect medical device manufacturers across the industry. We’ll be keeping a close eye on the Swiss-EU negotiations.

[1] 2017/745.

[2] https://ec.europa.eu/growth/single-market/goods/international-aspects/mutual-recognition-agreements_en

[3] https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf

[4] https://www.raps.org/news-and-articles/news-articles/2019/4/swiss-medtech-group-warns-of-whats-to-come-withou

[5] Article 15 MDR