Navigating Dual Certification: How to Stay Compliant Across the UK and EU
Navigating Dual Certification: How to Stay Compliant Across the UK and EU
28 January 2026
As we enter 2026, the post-Brexit regulatory landscape for medical devices continues to evolve, presenting both challenges and opportunities for manufacturers targeting the UK (Great Britain) and EU markets. With the EU's Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) fully in force, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) advancing its own reforms to the UK Medical Devices Regulations 2002, many companies are pursuing dual certification — maintaining CE marking for the EU while preparing for or achieving UKCA marking for Great Britain.
This edition explores practical strategies for dual CE and UKCA compliance, key differences between the regimes, current transition timelines, and how expert support can help you avoid pitfalls and maintain seamless market access.
Current Status: Transitional Arrangements and Deadlines (as of January 2026)
The MHRA has extended recognition of CE-marked devices in Great Britain to provide breathing room while core aspects of a strengthened UK framework roll out:
CE-marked devices remain accepted in Great Britain until June 2028 or June 2030, depending on device type (e.g., longer for certain higher-risk or legacy devices under transitional provisions aligned with EU extensions).
The UKCA marking is accepted now and will become the primary (or sole) route in the future, though recent MHRA consultations indicate potential removal of mandatory UKCA labelling once Unique Device Identification (UDI) is fully operational — with transitional periods of 3 years for general devices and 5 years for IVDs.
A major update to UK pre-market requirements is anticipated in 2026, bringing the UK framework closer to EU MDR principles (e.g., enhanced classification, post-market surveillance, and international reliance routes).
In 2025, the MHRA issued guidance regarding post-market surveillance that introduces requirements not fully aligned with those of the EU MDR and IVDR.
Northern Ireland continues under EU rules (CE marking required; UKCA not sufficient alone).
In short: Dual marking (both CE and UKCA on products/packaging where feasible) remains a valid and often recommended approach during this transitional phase.
Key Differences: EU MDR vs. UK Framework
While the UK's current rules draw heavily from pre-MDR EU Directives (with modifications), divergences are emerging:
Conformity Assessment Bodies — EU: Notified Bodies; UK: UK Approved Bodies (limited capacity historically, but improving).
Marking — CE for EU/EEA (including NI); UKCA for Great Britain (optional dual during transition).
Responsible Person — Non-EU manufacturers need an EU Authorised Representative to sell in EU; non-UK/GB manufacturers need a UK based Responsible Person (UKRP) to sell in the UK.
Classification & Routes — UK largely aligns with old EU rules but plans risk-based updates (e.g., for IVDs) and international reliance (e.g., on EU, US, or other trusted approvals) to speed access.
Post-Market Surveillance (PMS) — Both demand robust PMS, but UK emphasizes trend analysis, incident reporting, and public/user feedback; PSURs may differ in submission requirements.
UDI & Registration — Mandatory registration with MHRA (even for CE-only during transition); UDI rollout imminent in UK.
For many devices, an MDD/IVDD-compliant file can form the basis for UKCA with adjustments (e.g., UK-specific references, UKRP appointment).
Strategies for Successful Dual Certification
Maintain Parallel Technical Documentation Keep one core file with branches for EU MDR and UK requirements. This minimizes duplication while addressing gaps like UK legislation references or UKRP details.
Leverage Transitional Provisions Use CE acceptance in GB to delay full UKCA for legacy devices, but prepare now for 2026 changes and eventual mandatory elements.
Pursue Dual Marking Where Practical Affix both CE and UKCA marks on labelling/IFU/packaging (with appropriate Notified/Approved Body numbers). This future-proofs products and simplifies audits — many manufacturers adopt modular labelling systems.
Appoint Required Representatives Early Secure a UKRP for non-UK manufacturers and ensure EU AR compliance.
Engage Approved/Notified Bodies Strategically Some bodies offer both CE and UKCA services, streamlining processes.
Strengthen PMS and Clinical Data Align literature reviews, clinical evaluations, and post-market plans to satisfy both regimes — a common pain point for dual-market players.
Monitor MHRA Consultations Watch for late-2025/2026 updates on indefinite CE recognition, reliance pathways, and UDI.
How Maytal Can Support Your Dual Compliance Journey
At Maytal, we specialize in bridging regulatory gaps for medical device companies. Our services include:
Comprehensive gap analyses between EU MDR and UK frameworks.
Literature-based clinical evaluations and protocols tailored for dual submissions.
Post-market surveillance planning and investigation management.
Support for UKRP appointment, MHRA registrations, and documentation updates.
Whether you're a startup scaling into both markets or an established player updating legacy devices, our team helps you navigate complexity efficiently — saving time, reducing risks, and ensuring uninterrupted access.