Do German medical device manufacturers need a UKCA mark, or is the CE mark still accepted in the UK?

The MHRA currently continues to recognize valid EU CE marks for the Great Britain market, and recent 2026 proposals point toward indefinite recognition for EU MDR-compliant devices. However, regardless of whether you use a CE mark or transition to a UKCA mark, you are still legally required to register your medical devices directly with the MHRA and appoint a UK representative to sell in the UK.

What is a UK Responsible Person (UKRP) and do we need one?

Yes. Because your manufacturing facility is located outside of the UK, you are legally required to appoint a UK Responsible Person (UKRP). The UKRP must have a physical address in the UK and acts as your official regulatory liaison. They assume legal responsibility for registering your medical devices with the MHRA and maintaining access to your technical documentation for UK authorities.

How long does MHRA medical device registration take?

Once your technical file is compliant and your UKRP is officially appointed, the MHRA registration process typically takes a few weeks, provided all submitted data is accurate. Delays usually happen due to incomplete documentation, which is why our consultants review your technical files thoroughly before submission.

How does Operon Strategist assist with UK market entry?

We provide complete regulatory support for manufacturers expanding into Great Britain. Our consultants handle device classification under the UK MDR 2002, perform gap analyses between your existing EU MDR technical files and UK requirements, assist in setting up your UKRP, and execute the final MHRA registration to ensure smooth market access.

OPERON ELEVATEPLUS | UKCA MARKING FOR MEDICAL DEVICES

UKCA Marking Consultants & UK Responsible Person Services in Germany

Operon Strategist offers comprehensive UKCA and MHRA regulatory consulting for medical device manufacturers in Germany, guiding you through device classification, conformity assessment, documentation preparation, UK Responsible Person (UKRP) setup, and successful UK registration, simplifying your cross-border route to compliance.

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Operon ElevatePlus
UKCA Marking for Medical Devices Service Portfolio

UKCA Regulatory Strategy & Classification

Technical Documentation Preparation

MHRA Registration & Application Support

UK Responsible Person (UKRP) Assistance

Conformity Assessment & UK Approved Body Support

Post-Approval Support & Ongoing Compliance

What Sets Us Apart

Global exposure, structured thinking, and execution-ready expertise

UKCA Marking & MHRA registration – we support German medical device manufacturers in achieving UKCA Marking and MHRA registration through a structured conformity and regulatory alignment approach. Our services include device classification, definition of the appropriate conformity pathway—including navigating the latest UK reliance routes for CE-marked devices—and preparation of technical documentation aligned with UK MDR 2002, enabling compliant and confident access to the UK market.

Operon UKCA Marking for Medical Devices Advantage

Complete regulatory support for achieving UKCA (UK Conformity Assessed) compliance and MHRA device registration, enabling market access in Great Britain