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MHRA publishes draft policy statement on International recognition of medical devices

By May 22, 2024No Comments

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK.

This statement of policy intent is intended to inform partners of the MHRA’s direction of travel.  The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024 according to the MHRA’s roadmap. The MHRA intend to recognise medical and IVD devices that are approved by Australia, Canada, the EU and the USA.

The MHRA have proposed four market access routes, depending on type, class and prior approval of the device. For IVDs, these routes are:

  1. Recognition, self-registration with MHRA: Non-sterile Class A IVD devices that comply with devices legislation in Australia, Canada, the EU or the USA
  2. Reliance: Class A (sterile), Class B, C, and D IVD devices that comply with EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) only. This would exclude AIaMD and devices where the classification is different in the EU to that under the UK Medical Devices Regulations
  3. Reliance with device-specific requirements: Applies only to certain medical devices, not including IVDs
  4. Reliance with abridged assessment and device-specific requirements: Class A (sterile), Class B, C, and D IVD devices that comply with devices legislation in Australia, Canada or Premarket Approval, DeNovo or 510k legislation in the USA

The policy statement also provides details on the eligibility criteria and manufacturer requirements.

The MHRA intend to introduce transitional arrangements for UKCA marked devices along with the future core regulations. This will allow products to be placed on the market until either the certificate expires or for 3 years after the new regulations take effect (general medical devices) or 5 years (IVDs), whichever is sooner.

Next steps:

BIVDA will be holding a dedicated webinar on 31 May 2024, to go through this in more detail. Further information on this meeting will be provided in due course.

If you have any questions in the meantime, please send these to regulatory@bivda.org.uk.

 

Tehelj