UK device regulation operates under Medical Devices Regulations 2002 (transposing legacy EU MDD/AIMDD/IVDD) as amended post-Brexit. Conformity assessment routes: UKCA mark via UK Approved Body (Class IIa/IIb/III, IVDs requiring third-party review) or self-declaration (Class I non-sterile/non-measuring); UK(NI) mark requires EU MDR/IVDR conformity assessment via EU Notified Body under Windsor Framework. CE acceptance — CE-marked devices compliant with EU MDR/IVDR remain accepted on GB market through June 30, 2030 (general MD and IVD); legacy MDD/AIMDD CE accepted through June 30, 2028; legacy IVDD CE accepted through June 30, 2030. UK Approved Body capacity is limited (BSI, TUV SUD UK, DEKRA UK, SGS UK, LRQA among the small set). MHRA registration via Device Online Registration System (DORS) required regardless of conformity assessment route — manufacturer details, UK Responsible Person details (for non-UK manufacturers), GMDN code, device classification, conformity basis, Notified Body number, basic UDI-DI where applicable. UK Responsible Person obligations — hold technical documentation, maintain registration, cooperate with MHRA, vigilance reporting via MORE portal, post-market surveillance liaison; shared liability with manufacturer for non-conformities. Northern Ireland follows EU MDR 2017/745 and IVDR 2017/746 per Windsor Framework — UK(NI) market access requires EU NB conformity assessment with CE mark; UK Internal Market Scheme (UKIMS) for GB-NI movement; EU AR (often Ireland-based) covers EU + NI. UK MDR Reform — phased statutory instruments. First SI: Medical Devices (Post-market Surveillance Requirements) Amendment Regulations 2024 in force June 2025 aligning UK PMS with EU MDR Articles 83-86 (PMS plan, PMS report Class I, PSUR Class IIa/IIb/III, vigilance with serious incident definitions, trend reporting). Future reform expected to address pre-market conformity assessment, IVD classification, UDI implementation, SaMD/AI pathway, custom-made and patient-matched devices, clinical investigation reform and International Recognition Procedure for devices (FDA, Health Canada, TGA, PMDA).

Regulatory anchors

Medical Devices Regulations 2002 SI 2002/618
Medical Devices (Post-market Surveillance Requirements) Amendment Regulations 2024
Regulation (EU) 2017/745 (NI applicability)
Regulation (EU) 2017/746 (NI applicability)

Industries that live with this

Medical Devices Blood & Tissue Pharmaceutical

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Supplier portal — chase nothing. Score everything.

Suppliers log in, see what you need, submit it against your spec, and watch their scorecard. SCARs are raised, replied to and closed in the portal — not in your inbox.