In January 2024, the UK government postponed the mandatory implementation of UKCA markings and extended the recognition of European CE markings on medical and in-vitro medical devices.

Since the UK government introduced the UK Conformity Assessment (UKCA) on January 1, 2021, they have recognized both the CE and UKCA Markings. This grace period has been offered for businesses to comply with the new legislation. Nevertheless, the Medicines and Healthcare products Regulatory Agency (MHRA) will still accept European CE markings during an extended transition period, depending on the device type.

• General medical devices or active implantable medical devices up until the sooner of expiry of the certificate or 30 June 2028
• In vitro diagnostic medical devices (IVDs) up until the sooner of expiry of the certificate or 30 June 2030
• General medical devices, including custom-made devices and IVDs until 30 June 2030.

The legislation also provides new dates for self-declared CE marked Class I medical devices if:

• They are self-declared against EU MDR requirements (until 30 June 2030) or
• Self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028).

The MHRA is continuously reviewing future regulations for the safe supply of Medical Devices being imported to Great Britain. Given that UKCA markings will not be recognized in the EU, EEA, or Northern Ireland markets, manufacturers and importers will need to hold the relevant CE Markings for European markets or UKNI Markings for Northern Ireland markets.

Additionally, the MHRA is proposing a policy to recognize approvals of medical devices from international regulators, including Australia, Canada, the European Union, and the United States of America. This recognition will be based on device type, class, and prior approval. The goal is to streamline approvals, enhance patient access, and ensure safety. For more details, refer to the MHRA Statement.

Please contact our Marken team at TradeCompliance@marken.com if you have any questions.