UK MHRA Guidance: Regulation of Medical Devices in Northern Ireland: Step-by-Step Guide (2025)

On 24 July 2025, the UK Government published the latest update to its official guidance: "Regulation of medical devices in Northern Ireland – MDR and IVDR". This guidance explains how the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) continue to apply in Northern Ireland because of the Northern Ireland Protocol.

For medical device and diagnostics manufacturers, importers, and distributors, this guidance is essential reading to ensure compliance when placing products on the Northern Ireland market.

According to this guidance, products placed on the Northern Ireland market must meet EU conformity requirements (CE mark) and may also need the UKNI marking in some cases. The guidance clearly states that:

• The CE mark is still required to place medical devices and IVDs on the Northern Ireland market.

• Devices assessed by UK Approved Bodies can carry a UKNI mark but only for the NI market — these cannot be placed on the EU market.

• For EU-wide sales, a CE mark from an EU Notified Body is mandatory.

The MHRA continues to act as the regulator in Northern Ireland but must do so in line with EU law, as explained in the updated guidance.

As per the guidance:

• Manufacturers based outside NI and the EU (including GB companies) must appoint an EU-based Authorised Representative (AR) to market products in NI or the EU.

• A GB-based AR does not meet MDR/IVDR requirements for NI.

• All devices marketed in NI must be registered with the MHRA.

Manufacturers must also comply with full MDR/IVDR requirements for:

• UDI labelling

• Clinical evaluation / performance evaluation

• Post-market surveillance

Hospitals and labs can make and use devices in-house under the health institution exemption (Article 5(5)), if:

• Devices are only used within the institution

• Proper quality management and documentation are maintained

• The devices aren’t transferred to another legal entity

The guidance explains that:

• Bringing devices from Great Britain into Northern Ireland makes the NI business an “importer” under MDR/IVDR.

• Importers must:

  • Verify CE/UKNI marking and correct labelling

  • Keep technical documentation

  • Cooperate with MHRA

• Distributors must:

  • Keep records of complaints, recalls, and non-conforming devices

  • Check labelling and conformity before sale

  
  

  The guidance also covers clinical research:

  • Clinical investigations in NI must follow EU MDR requirements

  • Performance studies for IVDs must meet EU IVDR requirements

  • Applications must still be submitted to the MHRA

For complete details and FAQs, please read the full official guidance: Regulation of medical devices in Northern Ireland – MDR and IVDR