UK MHRA Proposes Indefinite Acceptance of CE-Marked Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation proposing the indefinite recognition of CE-marked medical devices in Great Britain. This move is intended to provide long-term regulatory clarity for manufacturers and ensure continued patient access to safe and effective medical technologies.
The agency noted that “most manufacturers have delayed transitioning to UKCA (UK Conformity Assessed) while the international reliance scheme was developed. As a result, approximately 90% of medical devices on the GB market remain CE marked today.”
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Key Highlights of the Proposal
Indefinite acceptance of CE-marked devices compliant with EU MDR and EU IVDR in Great Britain.
Alignment of certain transitional timelines with European Union deadlines.
Reduction of regulatory duplication for manufacturers supplying both the EU and UK markets.
Introduction of streamlined reliance pathways for certain higher-risk devices.
Currently, CE-marked devices are permitted in Great Britain under transitional arrangements following Brexit. If adopted, the proposal would eliminate uncertainty around expiry timelines and, in many cases, reduce the need for separate UKCA conformity assessment.
Read more about UKCA registration for medical devices.
Impact on the Industry
If implemented, this policy would:
- Lower compliance costs for global manufacturers
- Simplify market access to the United Kingdom
- Strengthen supply chain stability
- Support faster availability of innovative technologies for patients
The consultation remains open for stakeholder feedback before final regulatory decisions are made.
Role of Operon Strategist
Operon Strategist supports medical device manufacturers through:
- Regulatory impact assessment and strategic advisory
- Gap analysis between EU MDR, IVDR, and UK regulatory frameworks
- CE and UK market access planning
- Technical documentation review and compliance readiness
- Ongoing regulatory lifecycle management
Our team helps manufacturers navigate evolving UK and EU regulations while ensuring efficient, compliant, and cost-effective market entry strategies.
