MHRA publish an update on future medical device regulations

MHRA publish an update on future medical device regulations

MHRA have just (1 July) published an update on future medical device regulations in the UK.

Legislation now enables CE marked medical devices to be placed on the Great Britain market 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 the expiry of the certificate or?30 June 2028
  • 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?30 June 2030.

For further information, see the latest update on the?implementation of the future regulations for medical devices.?

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