The implementation and extensions of EU MDR/IVDR have caused significant stress on regulatory departments. These challenges have been compounded by Brexit and the UK’s announcement that it would not adopt EU MDR/IVDR and the Swiss National Council’s vote to allow FDA-approved devices into the Swiss market.
During the 2023 MedCon Conference in April, Michael Maier, VP of Strategic Regulatory and Quality at Veranex, and James Pink, Director of Medical at Element, provided updates on medical device regulation in Switzerland and the UK.
The Swiss Plan
Swizterland is not part of the EU market. It definitely chose not to join the EU in May 2021 after seven years of negotiations. To sell in Switzerland, medical devices need a CE Mark and a Swiss Authorized Rep (CH-REP).
The CH-REP obligations are outlined in MedDO Article 51/52. They are responsible for:
- Submitting PMS reports and PSUR reports to SwissMedic upon request
- Traceability between importers and distributors (MedDO Art. 64)
- Vigilance reporting
- Spontaneous trend reporting
- Maintaining a means to cover product liability claims
All of these obligations must be fixed in a written mandate agreement between the device manufacturer and its CH-REP.
MedDO Article 70 provides an exemption for niche products that allows healthcare providers to bring in a device—that is not yet approved under SwissMedic regulations—to treat a patient. The device must still be CE marked, but does not require a CH-REP.
The Swiss Parliament has mandated the Federal Council “to come up with a solution to allow FDA-cleared/approved devices on the Swiss market to avoid shortages.” This has not yet been completed. Maier noted that it will take until at least Q4 2024 to get a legal proposal on the table.
The United Kingdom
Pink referenced challenges for the Medicines and Healthcare products Regulatory Agency (MRHA) in developing post-Brexit regulations, as the UK wrote most of the EU MDR/IVDR regulations.
This year, the UK did adopt the extended transition timeline of EU MDR for implementation of any new regulations. “The UK is very concerned about device shortages,” said Pink.
Today, all medical devices need to be registered with MHRA, and manufacturers outside of the UK who want to reach the market in Great Britain must appoint a single “UK Responsible Person” for all of their devices. This representative will act on the manufacturer’s behalf to perform tasks, including product registration.
The Government plans to introduce new regulations by Spring 2023. These will bring into force transitional arrangements (see below) as well as increased PMS requirements. As it did with pharmaceutical drugs, the UK is developing a list of needed medical devices and technologies.
As part of its targeted transitional arrangements, the Government intends to do away with the current requirement in Medical Device Regulations 2002, which ends acceptance of CE marked medical devices on the Great Britain market on June 30, 2023. Instead, the intention is to allow CE marked medical devices to be placed on the Great Britain market according to the following timelines:
- General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2028
- In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2030
- General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until June 30, 2030.