Healthcare & Social Care Product compliance and marking

Placing medical devices on the Northern Ireland market

How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, CE marking, UKNI marking via UK Approved Bodies, EU Authorised Representative, and dual compliance for manufacturers selling in both GB and NI.

Northern Ireland
Guide summary

If you sell medical devices in Northern Ireland, you must follow EU rules (EU MDR/IVDR) and use CE marking. UKCA marking alone is not valid. You may need both CE and UKNI marks if using a UK Approved Body.

  • Follow EU MDR 2017/745 or IVDR 2017/746 rules for NI
  • CE marking required for NI market (UKCA alone not valid)
  • Use UKNI mark alongside CE if assessed by UK Approved Body
  • Non-EU manufacturers must appoint EU Authorised Representative
  • Different classification and evidence rules than GB
  • Market surveillance by MHRA in NI
  • Dual compliance needed if selling in both GB and NI
  • Keep CE marking indefinitely for NI (no 2028/2030 expiry)
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Northern Ireland

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Under the Windsor Framework, Northern Ireland follows EU medical device legislation, not the UK Medical Devices Regulations 2002 that apply in Great Britain. If you place medical devices on the NI market, you must comply with the EU Medical Devices Regulation 2017/745 (EU MDR) or the EU In Vitro Diagnostic Regulation 2017/746 (EU IVDR).

This means different classification rules, stricter clinical evidence requirements, and different conformity marking requirements compared with Great Britain.

Marking requirements for the NI market

Devices placed on the Northern Ireland market must bear a CE mark. UKCA marking alone is not valid for Northern Ireland.

You have two routes to CE marking for NI:

  • EU Notified Body: Obtain CE certification from an EU-based Notified Body. The CE mark is valid for the NI market (and the EU single market).
  • UK Approved Body: A UK Approved Body can conduct conformity assessment for the NI market. Devices must carry both the CE mark and the UKNI marking. The UKNI mark indicates that a UK (rather than EU) body conducted the assessment.

Important: The UKNI marking is not recognised in the EU. If you export to EU member states, use an EU Notified Body for CE marking without the UKNI mark.

EU Authorised Representative

Non-EU and non-NI manufacturers placing devices on the NI market must appoint an EU Authorised Representative. This is a separate requirement from the UK Responsible Person needed for the GB market. If you sell in both markets, you need both representatives.

Differences from the GB regime

The EU MDR/IVDR imposes significantly different requirements from the UK MDR 2002:

  • Classification: EU MDR has 22 classification rules (compared with 18 in the old EU Directives retained in GB law). Software and implantable devices are generally classified higher.
  • Clinical evidence: EU MDR requires more extensive clinical evidence, including Post-Market Clinical Follow-up (PMCF) studies.
  • Essential requirements: EU MDR uses General Safety and Performance Requirements (GSPRs) instead of the Essential Requirements in the old Directives.
  • UDI: The EU UDI system (EUDAMED) applies in NI, not the planned GB UDI system.
  • IVD classification: EU IVDR already uses risk-based Classes A-D (GB still uses the old Annex system, with transition expected in 2026).

Dual compliance for GB and NI

If you sell medical devices in both Great Britain and Northern Ireland, you must comply with both regulatory frameworks simultaneously. Common approaches include:

  • CE + UKCA dual marking: Obtain CE certification (from EU Notified Body or UK Approved Body with UKNI mark) for NI, and UKCA marking (from UK Approved Body) for GB. Most comprehensive but most expensive.
  • CE marking only (during transition): CE marked devices are accepted on both the NI market (permanently) and GB market (until 2028/2030 transition deadlines). Simplest single route during the transitional period.

Northern Ireland device guidance