Regulation of medical devices in Northern Ireland
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Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 8
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers. Consult the original guidance for current legal and operational details.
Contents
- Overview
- The application of EU MDR and IVDR in Northern Ireland
- Manufacturers and authorised representatives
- Notification of interruption or discontinuation of the supply of a medical device for manufacturers based in Northern Ireland
- Post-market surveillance
- Conformity assessment and regulatory marking
- UK(NI) marking
- Unfettered access of qualifying Northern Ireland goods
- Health institutions in Northern Ireland
- Importers and distributors in Northern Ireland
- Notification of interruption or discontinuation of the supply of a medical device for importers and distributors based in Northern Ireland
- Labelling requirements
- European database on medical devices (EUDAMED)
- Who must register as 'Actors' on EUDAMED?
- Who must register the medical device on EUDAMED?
- Clinical investigations and performance studies in Northern Ireland
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Regulation of medical devices in Northern Ireland’ (updated 11 June 2026), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026