MHRA consultation on indefinite recognition of CE-marked devices (GB)
Key Questions
What is the MHRA consultation about?
The MHRA launched a March 2026 consultation proposing three approaches for the indefinite recognition of EU CE certificates for about 90% of devices in Great Britain (GB). It addresses open questions on scope, oversight, liability, and UKCA marking, reinforced by FDA-MHRA mutual recognition and tariff lifts in April 2026.
Which devices are affected by the proposed indefinite CE recognition?
The proposal covers approximately 90% of medical devices currently holding EU CE certificates for use in GB. It includes considerations for Northern Ireland (NI) guidance on CE/UKNI labeling and post-market surveillance (PMS) splits.
What actions are recommended for stakeholders?
Stakeholders should model scenarios, engage UK Responsible Persons (UKRPs), and submit responses to the consultation by April 10, 2026. This helps shape decisions on oversight, liability, and transition from UKCA marking.
How does this relate to FDA-MHRA collaboration?
The consultation is supported by FDA-MHRA mutual recognition agreements and tariff lifts effective April 2026, aiming to maintain close ties between US FDA, MHRA, and EU regulators for medical devices.
What are the key open issues in the consultation?
Key issues include defining the scope of recognition, oversight mechanisms, liability responsibilities, and the role of UKCA marking. Responses will influence final guidance on EU authorised representatives and labeling in GB and NI.
MHRA March 2026 consultation proposes three approaches to indefinitely recognise EU CE certificates (90% devices) for GB; reinforced by FDA-MHRA mutual recognition/tariff lifts (April 2026) and NI guidance on CE/UKNI labeling/PMS splits. Open on scope/oversight/liability/UKCA; model scenarios, engage UKRPs, submit responses by Apr 10.