MRA Background
The Switzerland–United Kingdom Mutual Recognition Agreement on conformity assessment for medical devices was signed in December 2021 following the UK's withdrawal from the EU regulatory framework. The agreement initially covered Class I devices and Class IIa non-active devices. This update, negotiated over 14 months, extends the mutual recognition scope in response to industry feedback that the previous scope covered fewer than 30% of traded device value between the two countries.
Expanded Scope — New Device Classes
The updated annex adds Class IIa active devices and Class IIb non-implantable devices to the mutual recognition scope. Under the expanded MRA, a valid UKCA certificate issued by a UK Approved Body will be accepted by Swissmedic as the conformity assessment basis for Swiss market registration, and vice versa, eliminating the need for duplicate conformity assessments for these device categories.
Post-Market Surveillance Equivalence Review
For devices relying on the MRA for the first time under the expanded scope, manufacturers must complete a post-market surveillance equivalence review within 12 months of first placement on the receiving market. This review confirms that the PMS plan addresses specific national adverse event reporting obligations that differ between Swiss and UK frameworks, particularly regarding periodic summary reporting timelines.
Excluded Categories
Class IIb implantable devices and Class III devices remain outside the expanded MRA scope pending further technical alignment discussions on clinical evidence standards. Swissmedic and the UK MHRA have indicated a target of extending the MRA to these categories by mid-2028.