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DHSC have provided the following update for stakeholders:

You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol.

This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of what this means for all products and supply chains and will revert with further information on these arrangements in due course.

The deal does not include any changes to the regulatory arrangements for placing medical devices on the market in Northern Ireland.

Separately, it may be of interest to you that the deal includes significant changes to medicine regulatory arrangements, most importantly:

  • The replacement of the EMA by the MHRA as Northern Ireland’s regulator for all novel medicines, making the MHRA the sole medicines regulator for Northern Ireland.
  • The disapplication of the Falsified Medicines Directive in Northern Ireland.
  • A requirement for UK medicines to carry a ‘UK-only’ marking.

Further detail can be found on here. More detail on medicines and other arrangements can be found in the sector explainers here.

We will continue to work closely with you to address issues that arise in relation to the supply of medical devices to Northern Ireland, which remains a priority. If you have any questions or concerns in relation to the supply of medical devices to Northern Ireland, please get in touch with us.

BIVDA have requested further clarity from MHRA on whether this agreement includes medical devices. We will provide more information as soon as possible.