September 13, 2025
While they are all part of European continent, there are still some differences between the European Union (EU) member states, Switzerland and the United Kingdom (UK). In the past Switzerland and the EU had a Mutual Recognition Agreement (MRA), which allowed medical devices and IVDs to circulate freely between Switzerland and the EU, without for example the need to appoint a Swiss Representative (CH-REP). A similar scenario has emerged in the UK, where third country manufacturers were not required to appoint a UK Representative (UKRP) prior to the UK leaving the EU. Situations in Switzerland and the UK have led to additional registration requirements as well as the requirement for third-country manufacturers to appoint an in-country representative.
During a Sept. 4 Medical Device Coordination Group (MDCG) meeting on International Matters, stakeholders such as the European Association of Authorized Representatives (EAAR) received some insight on what is currently developing in the EU, UK and Switzerland when it comes to market access and harmonization of requirements across the continent.
The UK and acknowledgement of the CE mark
While the UK and Switzerland have not adopted the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), they do acknowledge CE-marked devices, which are compliant with the EU regulations. Nevertheless, the UK had adopted its own medical device regulation, the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR), which applies to medical devices and in vitro diagnostic devices. While CE-marked devices are currently still recognized in the UK, manufacturers will have to obtain UK Conformity Assessment (UKCA) certification starting from June 30, 2028 for medical devices and June 30, 2030 for IVDs. There is some welcome news for manufacturers marketing in the UK, as the UK proposed to indefinitely acknowledge the CE mark, in parallel with new reliance routes for trusted regulators in Australia, Canada and the U.S.
Switzerland and the MRA with the EU
Currently all eyes of the European Commission (EC) are currently focused on the revision of the Regulations, which may have led to the fact that there is no new information to share on the MRA between Switzerland and the EU. What is known is that Switzerland faces steeper tariffs from the U.S. (39% on Swiss goods exported to the U.S. market) than the EU (15%). These conditions are expected to help push towards a new MRA. The Swiss Federal Council emphasized that there is a “strategic necessity for Switzerland to maintain stable and predictable relations with the EU,” and as such has decided to hold an optional referendum on the EU agreements (the consultation process will end 31 October 31, 2025). If a new MRA is signed, it may no longer be a requirement to appoint a CH-REP. Switzerland’s most important trading partner is the EU and an MRA with the EU would stand to benefit the Swiss economy.
Homogenization and revisions of the Regulations
The EC has summarized and analyzed the public consultation that took place from Dec. 12, 2024 to March 21, 2025, and has launched a new consultation to “simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework.” One of the goals here is reduction of administrative burdens, as well as enabling international cooperation including reliance, where appropriate.
During the Sept. 4 MDCG International matters meeting, Notified Bodies emphasized that while all eyes are on the revision of the Regulations, there are currently already well-structured harmonized Medical Device Single Audit Program (MDSAP) quality management system (QMS) audit templates available, with an output report that could meet the requirements of Article 10 of the MDR and Article 10 of the IVDR. If the EC would acknowledge these MDSAP templates and allow their use by Notified Bodies for EU conformity assessments, this would reduce administrative tasks and provide more efficiencies for Notified Bodies and manufacturers. With the current call for evidence, the EU might get a step closer to acknowledgment of (certain parts of) MDSAP certification.
Conclusion: Greater international reliance and harmonization
International reliance and harmonization are becoming more important for regulators all over the world. While all medical device legislation aims to support safer and more effective devices, with a high level of public health and patient safety, legislation often causes barriers. These barriers may lead to innovative and safe devices not being available for patients in one jurisdiction compared to another. Emergo by UL welcomes international harmonization of legislation to enable market access and availability of needed healthcare to patients.
Emergo takes part in several European MDCG meetings, and will provide additional updates as they become available.
