Medical Devices in the UK: extension for CE marked devices

With Brexit, the legislation of the European Union does not apply in the United Kingdom anymore. Currently, the Medical Device Regulations 2002 (UK MDR 2002) applies. However, the country aims at implementing the new Regulations on medical devices in the near future.

On October 25, 2022, the government of the United Kingdom announced a 12-month extension to the standstill period (acceptance of CE marked devices). This changes the previous plan to accept CE marked devices until June 2023, defined by the UK MDR 2002. This extension will be soon reflected in the law.

Transitional period and arrangements

With this announcement, manufacturers can place CE marked medical devices on the market in Great Britain until June 2024. After this date, transitional arrangements for CE and UKCA marked devices will apply on the GB market, with the new Regulations being introduced by Spring 2023.

MDlaw will keep you informed about all developments on the future UK law.

Check out our UK-dedicated section in our Library of Documents!

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