The UKRP rule
Non-UK manufacturers appoint a single UKRP — and every device must be registered with the MHRA before market.
Free field guide · PDF
UK MHRA Medical Device Registration2026 Field Guide
The UKRP rule, CE transition deadlines, and the reform timeline to 2028 — under the 2026 amendment regulations.
- CE transition ends
- Jun 2028
- Enhanced PMS live
- 16 Jun 2025
- UDI mandatory
- 1 Jun 2027
Sourced from MHRA 2026 guidance and the transition record.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — MHRA 2026 guidance and the transition record.
The CE transition
CE-marked devices stay on the GB market to 30 June 2028 (MDD/AIMDD) or 30 June 2030 (MDR/IVDR).
The reform timeline
Enhanced PMS since 16 June 2025, 2026 amendment regulations, UDI from 1 June 2027, reliance pathway from 2028.
Sources & scope
- tracekey.com, MedTech regulations in the UK.
- pharmadocx.com, introduction to UK Conformity Assessed (UKCA).
- legislation.gov.uk, Medical Devices (Post-market Surveillance Requirements) 2024.
- lexology.com, UK MHRA medical device standstill extension.
This guide is market-access intelligence, not regulatory or legal advice. UK MDR reform timelines, transition rules, and UKRP obligations are product-specific — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your MHRA route — UKRP selection, CE-transition timing, and UKCA planning.
Professional review is required before business use.
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