RAPath UK
UK Medical Device Regulatory Reference — MHRA & UK MDR 2002
RAPath UK is a plain English reference for UK medical device regulation under the UK Medical Devices Regulations 2002 (SI 2002/618, as amended) and associated legislation. It is designed for regulatory affairs professionals, manufacturers, UK Responsible Persons (UKRPs), importers, consultants, and anyone navigating the UK framework.
This site does not replace official sources. Every page links back to the authoritative legislation text, MHRA guidance, or official Government publication. Think of RAPath UK as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative source.
Manufacturers (UK and non-UK) — understand what UK MDR 2002 requires of you, from classification through to ongoing post-market obligations, for both the GB and NI markets.
UK Responsible Persons (UKRPs) — understand your joint responsibility with overseas manufacturers under the post-Brexit GB framework.
Importers and distributors — understand your verification, record-keeping, and cooperation obligations.
Anyone new to UK medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device under UK MDR 2002:
| Section | What it covers |
|---|---|
| Start Here | Definitions, the GB vs NI dual-market position, regulatory framework, key roles (including UKRP), device lifecycle, post-Brexit transition timeline, glossary |
| Pre-Market | Classification (Schedule 2 Rules 1–18), Essential Requirements, technical documentation, conformity assessment routes (self-declaration, UKAB routes), MHRA registration, clinical evidence, and 8 special device types |
| Post-Market | Post-market surveillance, PSURs, PMCF, vigilance reporting to MHRA, FSCAs and recalls, MHRA registration maintenance, and labelling and advertising |
| Legislation | UK MDR 2002 structure, all Schedules, post-Brexit amending instruments, Medical Devices Act 2021, UK-designated standards, and how to read UK legislation |
| UK Approved Bodies | What UKABs are, how to find one, the audit and certification process, certificate types, and transitioning from EU Notified Body certificates |
| Northern Ireland | NI's dual-market position — EU MDR/IVDR in NI vs UK MDR 2002 in GB, Windsor Framework, UKCA vs CE vs UKNI, practical multi-market compliance |
| Guidance Documents | MHRA guidance indexed by topic, the Submissions portal how-to, forms, fees, and timelines |
| What's New | Recent regulatory changes, open consultations, upcoming changes, UKCA/CE deadline tracker |
| Special Access | Exceptional Use Authorisations, Approved for Use, clinical investigation access, custom-made device exemption |
A UK-unique regulatory landscape
RAPath UK addresses regulatory features that have no parallel in the EU, Australian, Canadian, or Singapore frameworks:
- GB vs NI dual-market position — two regulatory regimes (UK MDR 2002 / EU MDR-IVDR) operating simultaneously within one political territory
- The Windsor Framework — the 2023 UK-EU agreement governing NI's continued EU alignment
- UK Responsible Persons (UKRPs) — the post-Brexit legal representative role for non-UK manufacturers accessing the GB market
- CE marking transitional acceptance — CE marking valid on the GB market until 30 June 2030
- UKCA marking — the UK conformity mark, replacing CE marking for GB from 2030
Pages covering UK-unique content are marked with a UK-unique badge throughout the site.
Where to start
If you are new to UK medical device regulation: → What is a medical device?
If you need to understand the GB vs NI split: → Great Britain vs Northern Ireland
If you need to classify a device: → How classification works
If you are a non-UK manufacturer entering the GB market: → Who needs to comply?
If you are planning UKCA transition: → Post-Brexit transition timeline
If you need to report a serious incident: → What must be reported to MHRA
If a recall may be required: → When an FSCA is required
Questions, corrections and discussions
RAPath UK is a community reference. If you find an error, have a regulatory question, or want to discuss a recent UK MDR development, use GitHub Discussions:
Regulatory affairs professionals who flag inaccuracies are the most valuable contributors to this project.
Disclaimer
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official legislation.gov.uk and MHRA sources before making regulatory decisions. This site is not affiliated with MHRA or any UK Government body. Not legal or regulatory advice.