United Kingdom medical device regulations
Official sources linkedMHRA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| SI 2024/1368 | The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 Amending instrument for UK MDR 2002 post-market surveillance. Made 16 December 2024; regulation 1(2) brings it into force 6 months after the day it was made (16 June 2025). | Vigilance | June 16, 2025 | Official |
| SI 2002/618 | The Medical Devices Regulations 2002 Current revised expression of the UK Medical Devices Regulations 2002 from legislation.gov.uk. Covers general medical devices (Part II), active implantable devices (Part III), and IVDs (Part IV). | Registration | June 13, 2002 | Official |
| SI 2002/618 (current) | Medical Devices Regulations 2002 - current revised expression Duplicate metadata row for the same current legislation.gov.uk expression already ingested as uk-mdr-2002. Not a second corpus copy. | Registration | June 13, 2002 | Official |
| UK Approved Bodies | UK Approved Bodies for Medical Devices GOV.UK collection of approved-body information. Not an ingestible legal instrument for this family. | GMP/QMS | — | Official |
| MHRA Clinical Investigation Guidance | Clinical Investigations of Medical Devices GOV.UK clinical-investigation guidance page. Not ingested as UK MDR source text. | Clinical Trials | — | Official |
| Future UK Medical Device Regulations | Implementation of Future Medical Device Regulations Policy/implementation page for future legislation, not a current binding instrument. Not ingested. | Registration | — | Official |
| MHRA Registration Guidance | Register Medical Devices to Place on the UK Market GOV.UK guidance page, not the UK MDR instrument. Left as discovery metadata for later P1 guidance ingest. | Registration | — | Official |
| MHRA Software Guidance | Guidance on Software as a Medical Device GOV.UK software guidance collection. Exact-file ingest belongs with P1 guidance, not the UK SI family. | Software/SaMD | — | Official |
| UKCA Marking Guidance | UKCA Marking for Medical Devices GOV.UK overview guidance, not an exact statutory instrument. Not ingested as source text in this family. | Labeling | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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