Skip to main content

Rules applying in Northern Ireland

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 specific EU regulatory rules that apply in Northern Ireland — EU MDR 2017/745, EU IVDR 2017/746, CE marking, EU Notified Bodies, and EUDAMED registration.

EU MDR 2017/745 in Northern Ireland​

Regulation (EU) 2017/745 (EU MDR) applies to general medical devices placed on the Northern Ireland market. This includes:

  • Classification under MDR Rules 1–22 (not UK MDR 2002 Schedule 2 rules)
  • Conformity assessment under MDR Annexes IX–XI
  • CE marking requirement
  • EUDAMED registration
  • EU Notified Body involvement for Class IIa, IIb, III, AIMD, and Class IIb implants
  • Full MDR post-market obligations (PSUR, PMCF, vigilance to MHRA in EU CA capacity)
  • Annex XVI non-medical purpose devices (non-corrective contact lenses, fillers, etc.) are regulated in NI — but NOT in GB

EU IVDR 2017/746 in Northern Ireland​

Regulation (EU) 2017/746 (EU IVDR) applies to IVD medical devices placed on the Northern Ireland market. This includes:

  • Classification under IVDR Rules 1–7 (Class A, B, C, D — not UK MDR 2002 Part III Annex II lists)
  • Conformity assessment under IVDR Annexes IX–XI
  • CE marking requirement
  • EUDAMED registration
  • EU Notified Body involvement for Class B, C, and D IVDs

EUDAMED registration​

Devices placed on the NI market must be registered in EUDAMED, the EU medical device database, by the manufacturer or EU Authorised Representative. MHRA Submissions portal registration (GB registration) is separate and does not substitute for EUDAMED registration for NI market access.

Official references​

ReferenceDescription
EU MDR 2017/745Applies in NI — full text
EU IVDR 2017/746Applies in NI — full text
EUDAMEDEU medical device database — registration required for NI market