UK MDR 2002 — overview & structure
The UK Medical Devices Regulations 2002 (SI 2002/618) is the primary legislation governing medical devices in Great Britain. The consolidated, amended text is available at legislation.gov.uk.
Structure of the UK MDR 2002
The UK MDR 2002 is divided into three Parts, each governing a distinct category of medical device:
| Part | Scope | Derived from | Key Schedules |
|---|---|---|---|
| Part I | General medical devices — Class I, IIa, IIb, III | EU MDD 93/42/EEC | Schedule 1 (ERs), Schedule 2 (Classification rules), Schedule 3 (Conformity assessment annexes) |
| Part II | Active implantable medical devices (AIMDs) | EU AIMDD 90/385/EEC | Part II Schedule 1 (ERs), Part II Schedule 3 (Conformity assessment) |
| Part III | In vitro diagnostic medical devices (IVDs) | EU IVDD 98/79/EC | Schedule 1A (ERs for IVDs), Annex II (IVD classification lists), Annex III–VII (Conformity assessment) |
Each Part is self-contained — the classification, essential requirements, and conformity assessment rules for each device type are in the relevant Part, and the Parts are applied independently.
Key provisions of Part I (general devices)
Regulation 2 — Definitions, including the definition of a medical device, manufacturer, UKRP, importer, and distributor.
Regulation 3 — Custom-made devices and their exemption from standard conformity assessment.
Regulation 7 — General prohibition on placing devices on the market that do not meet the UK MDR 2002 requirements.
Regulation 7A — Combination products (drug-device combinations) and determination of principal mode of action.
Regulation 12 — Systems and procedure packs.
Regulation 16–22 — Vigilance reporting obligations.
Schedule 1 — Essential Requirements for general devices and AIMDs.
Schedule 2 — Classification rules (Rules 1–18) for general devices.
Schedule 3 — Conformity assessment procedures (Annexes I–VII equivalent).
Post-Brexit amendments
The UK MDR 2002 was substantially amended by SI 2019/791 (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019) to operate as standalone GB law. Key changes made by SI 2019/791:
- Replaced references to "CE marking" with "UKCA marking" as the primary conformity mark for GB
- Established the UK Responsible Person (UKRP) role — the GB equivalent of the EU Authorised Representative
- Replaced references to "Notified Bodies" with "UK Approved Bodies"
- Established MHRA as the sole competent authority for GB
- Preserved the Northern Ireland Protocol provisions (now updated by the Windsor Framework)
Subsequent statutory instruments have further amended the Regulations — principally to extend transitional arrangements for CE marking and MHRA registration. A tracker of amending instruments is in Post-Brexit amending instruments.
The Medical Devices Act 2021
The Medical Devices Act 2021 is primary legislation that grants the Secretary of State broad powers to:
- Amend UK MDR 2002 and related regulations by statutory instrument
- Introduce new device categories or requirements without primary legislation
- Implement the reformed UK medical device regulatory framework that MHRA is developing
This Act is the legal basis for MHRA's ongoing reform programme and for the various transitional deadline extensions announced since 2021.
How to navigate the UK MDR 2002
The current, consolidated text of the UK MDR 2002 — incorporating all amendments — is at:
legislation.gov.uk/uksi/2002/618/contents/made
Use the "Revised" version to see the text as currently in force. See How to read UK legislation for a guide to using legislation.gov.uk.
Related pages
- Schedule 1 — Essential Requirements
- Schedule 2 — Classification rules
- Schedule 3 — Conformity assessment
- Post-Brexit amending instruments
- UK-designated standards
- How to read UK legislation
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 | Full consolidated text |
| SI 2019/791 | Primary post-Brexit amending instrument |
| Medical Devices Act 2021 | Enabling powers for reform |