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Medical Device and Medicine Regulation Post-Brexit – where to begin?

On 1 January 2021 the Brexit transition period came to an end.

The UK is no longer required to comply with EU regulation.

Divergence from the EU is expected, the extent to which is yet to be seen. One area where we have already witnessed this parting is in the field of medical devices and medicines.

The relationship, as it currently stands between the EU and the UK, in respect of the regulation for medical devices and medicines, ceased in January 2021. In September 2020 ( as updated in December 2020), the UK Medicine and Healthcare products Regulatory Agency (MHRA) published a variety of guidelines to shed some light on what businesses operating in these fields can expect. To provide a flavour, here are some of the highlights that took effect from 1 January 2021.

Medicines

  • Responsibilities of the European Medicines Agency (EMA): the MHRA will, for the purposes of the UK, take responsibility for all decisions and functions which were previously handled by the EMA. There is one main exception to this – the EMA will continue to take responsibility for decisions over applications for Marketing Authorisation (MA) made via the EU procedure for purposes of marketing medicines in Northern Ireland.
  • Centrally authorised EU MAs: All centrally authorised EU MAs which are existing as of 1 January 2021, for the purposes of supply of medicines to Great Britain, will automatically convert to UK MAs. Existing EU MAs which have been centrally authorised will remain valid for marketing products to Northern Ireland.

Medicinal Devices

  • Medical Device Regulations: Now the transition period has come to an end, the UK Medical Devices Regulations 2002, as amended and in the form in which they exist on 1 January 2021 (UK MDR 2002), will remain as the key legislation applicable to medical devices in Great Britain.
  • EU Medical Device Regulations: The UK MDR 2002 will not include the amendments that would have been introduced by the new EU Medical Devices Regulation and the EU in vitro Diagnostic Medical Devices Regulation, which only come into force in the EU next year. For the purposes of medical devices in Great Britain, the UK MDR 2002 will be supplemented by the Medicines and Medical Devices Bill which is currently being discussed in parliament.
  • UK Registration: Manufacturers wishing to place a medical device on the UK market will need to register with the MHRA. Manufacturers based outside the UK will need to designate a ‘Responsible Person’ based in the UK to register and act on its behalf.

On 31 December 2020, the MHRA published further guidance (available here), which provides further practical pointers as to how medical devices are governed in a post-Brexit UK, including clarification regarding the introduction of grace periods for compliance in respect of certain categories of medical devices.

It would be prudent for businesses involved in UK – EU cross border trade of Medical Devices and Medicines to become familiar with the guidelines published by the MHRA. The changes to the relationship between the UK and the EU will throw up some practical and legal challenges for business which will need to be satisfied in a post-Brexit environment.

If you would like to discuss any of the points raised in this article, please do not hesitate to get in touch.

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