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The Windsor Framework — what changed in 2023

Regulatory basis

See the official sources listed in the references table at the bottom of this page.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice.

Overview​

The Windsor Framework agreed in March 2023 replaced the Northern Ireland Protocol — what changed for medical device regulation in NI, and what remained the same.

What is the Windsor Framework?​

The Windsor Framework is a political agreement between the United Kingdom and the European Union, finalised in March 2023. It replaced the earlier Northern Ireland Protocol on Ireland/Northern Ireland and governs Northern Ireland's continued alignment with EU single market rules.

What changed for medical devices​

The Windsor Framework made some practical adjustments to how NI rules operate:

Green Lane for GB-origin goods: Goods manufactured in Great Britain and moved to Northern Ireland for sale and final use in NI can use a simplified "Green Lane" customs process — reducing red tape for GB-to-NI shipments. However, the devices must still comply with EU MDR/IVDR to be placed on the NI market — the Green Lane addresses customs/movement formalities, not product regulatory requirements.

Stormont Brake: The NI Assembly gained a mechanism to object to new EU rules being automatically applied in NI, subject to UK–EU agreement. This has limited immediate impact on medical device regulation — EU MDR and EU IVDR continue to apply in NI.

Continued EU alignment: The Windsor Framework confirmed that NI continues to follow EU single market rules for goods, including EU MDR 2017/745 and EU IVDR 2017/746. This fundamental alignment was not changed by the Framework.

What did NOT change​

  • EU MDR 2017/745 still applies in NI for general medical devices
  • EU IVDR 2017/746 still applies in NI for IVD medical devices
  • CE marking is still required for the NI market
  • EU Notified Bodies are still required for devices needing third-party assessment for NI
  • EUDAMED registration is still required for devices on the NI market
  • MHRA still acts as competent authority for NI in an EU regulatory context

Official references​

ReferenceDescription
Windsor Framework (March 2023)UK–EU agreement text
MHRA: Windsor Framework guidanceMHRA's practical guidance
EU MDR 2017/745Continues to apply in NI