Post-Brexit amending instruments
This page covers official UK legislation. Always verify against the current consolidated text at legislation.gov.uk.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
The statutory instruments that have amended the UK MDR 2002 since Brexit — principally SI 2019/791 and subsequent instruments extending transitional arrangements and introducing regulatory changes.
Principal amending instruments
SI 2019/791 — Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
The primary post-Brexit amendment. Made the UK MDR 2002 operable as standalone GB law by:
- Establishing MHRA as the sole competent authority
- Introducing the UKCA mark as the GB conformity mark
- Establishing the UKRP role
- Replacing "Notified Body" with "UK Approved Body"
- Introducing MHRA registration requirements
Subsequent statutory instruments
A series of further statutory instruments have extended transitional deadlines and made technical amendments. Key extensions include:
- Extension of CE marking acceptance in GB (most recently to 30 June 2030 — June 2023 announcement)
- Phased MHRA registration requirements
A complete, up-to-date list of amending instruments is maintained on legislation.gov.uk.
The Medical Devices Act 2021
Medical Devices Act 2021 — primary legislation enabling further reform by statutory instrument. MHRA's reform programme will produce the next generation of amending instruments under these powers.
Official references
| Reference | Description |
|---|---|
| SI 2019/791 | Primary post-Brexit amendment |
| UK MDR 2002 — all related legislation | legislation.gov.uk listing with all amendments |
| Medical Devices Act 2021 | Enabling powers |