The MHRA has launched a consultation on proposals for indefinite recognition of CE-marked medical devices in Great Britain (GB), aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies.
Around 90% of medical devices currently used in Great Britain are CE marked, and the MHRA believes the proposals for indefinite recognition would ensure consistent long-term supply to support the health system.
The consultation seeks feedback on the proposals to extend arrangements put in place in 2023 to recognise CE marked devices, and forms part of the MHRA’s wider programme of regulatory reform of medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.
The consultation seeks views on three key proposals:
- Extending current transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning GB timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR), to minimise the risk of supply disruption.
- Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in GB.
- Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access.
Neil Plumridge, BIVDA’s Regulatory Affairs Manager, said, ‘BIVDA appreciates MHRA’s consultation on indefinite CE recognition, especially as the majority of IVD medical devices on the GB market currently rely on CE Conformity Assessment as the basis of their registration.
‘Where possible, avoidance of additional barriers, both financial and administrative to placing or retaining IVD medical devices on the UK market should be avoided for the benefit of patients. We will consult with our members on the options presented and provide feedback to the consultation.’
If responding to the consultation, please send your response to regulatory@bivda.org.uk for inclusion in BIVDA’s sector-wide response.
