Summary
Consultation description
The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain.
We welcome the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations.
We are inviting views on the following proposals:
- Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation
- Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), and
- Introduction of an international reliance route for devices classified higher in Great Britan than in the EU.
This consultation applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.
Download the report here.
