Northern Ireland medical device requirements under the Windsor Framework
Medical device regulatory requirements specific to Northern Ireland under the Windsor Framework, where EU MDR 2017/745 and EU IVDR 2017/746 apply instead of the UK MDR 2002.
Under the Windsor Framework, Northern Ireland follows EU medical device
legislation, not the UK Medical Devices Regulations 2002 that apply in
Great Britain. The EU Medical Devices Regulation 2017/745 (EU MDR)
and EU In Vitro Diagnostic Regulation 2017/746 (EU IVDR) apply
in Northern Ireland.
This means different classification rules, stricter clinical evidence
requirements, and different essential requirements (General Safety and
Performance Requirements instead of Essential Requirements) compared
with Great Britain.
The MHRA acts as market surveillance authority in Northern Ireland
but does not act as the conformity assessment authority for NI devices.
- Regulatory framework
- EU Medical Devices Regulation 2017/745 (EU MDR) and EU In Vitro Diagnostic Regulation 2017/746 (EU IVDR)
- GB equivalent
- UK Medical Devices Regulations 2002 (as amended)
- CE marking
- Required for the Northern Ireland market
- UKCA marking
- NOT valid on its own for the Northern Ireland market
- UKNI marking
- Required alongside CE mark when a UK Approved Body has been used for conformity assessment
- EU Notified Body certification
- Accepted with CE mark for the Northern Ireland market
- UK Approved Body role in NI
- Can issue CE mark plus UKNI mark for devices placed on the NI market
- EU Authorised Representative
- Required for non-EU and non-NI manufacturers placing devices on the NI market (separate from UK Responsible Person requirement for GB)
- UK Responsible Person
- NOT required for the NI market (applies to GB only)
- Unique device identification (UDI)
- EU UDI system (EUDAMED) applies in NI, not the planned GB UDI system
- Dual compliance
- Manufacturers selling in both GB and NI must comply with both regulatory frameworks simultaneously
- Market surveillance authority
- Medicines and Healthcare products Regulatory Agency (MHRA)
- IVD transition timeline
- Follows EU IVDR 2017/746 timeline, not GB IVD reclassification timeline
- Implementing legislation
- Medical Devices (Northern Ireland Protocol) Regulations 2021 (SI 2021/905)
- Market surveillance legislation
- Market Surveillance (Northern Ireland) Regulations 2021 (SI 2021/858)