MHRA publishes UK government’s response to public consultation on future routes to market for medical devices designed to modernise regulation
In this blog, Eamonn McGowan, Associate Director, Regulatory Affairs at Boyds, explores the latest steps the MHRA has announced and what each of these will entail.
On 23 July, the MHRA announced important new steps to secure access for patients to the latest medical technologies available in Europe and other advanced countries. As part of the proposal, the MHRA outlines 3 new approaches on international reliance, UKCA marking and IVDs.
International reliance
The UK intends to implement three of the proposed routes to market (Routes 1, 3 and 4) and expand the scope of the scheme (via Route 4) to include software as a medical device and implantable Class IIb and Class III medical devices that comply with 510(k) legislation in the USA, subject to the demonstration of entire equivalence. Detailed guidance will be published to support this scheme.
In addition, the UK is looking to indefinitely accept CE marked products from Europe – MHRA will conduct a consultation later this year on this. Currently, as a result of Brexit, the CE mark is recognised in Great Britain only until 30 June 2028 for higher‑risk devices and 30 June 2030 for lower‑risk ones. The government now proposes to remove that expiry and keep CE recognition without a sunset clause.
UKCA marking
The government intends to remove the requirement for UKCA marking. The UKCA marking requirements will be removed once Unique Device Identification (UDI) is in place. Once the national Unique Device Identification (UDI) database is fully operational, the MHRA will accept digital traceability in place of the logo.
In vitro diagnostic (IVD) devices
The government will amend the conformity assessment routes for Class B IVD devices (including software IVD devices), requiring UKCA self-assessment of conformity with the regulations and Quality Management System (QMS) certification to ISO 13485 before they can be placed on the Great Britain market.
QMS certification issued by UKAS-accredited bodies or, for Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) countries, International Accreditation Forum (IAF) accredited bodies will be permitted.
To ensure manufacturers are able to comply with updated requirements, a transition period will be commensurate with the scale of the changes and comprehensive guidance will be published.
Class A and B IVD devices will remain in scope of the international reliance scheme.
UK will also look to recognise SaMD devices with appropriate Australian, Canadian and American approvals – on condition they can demonstrate ‘entire equivalence’, where technical, biological and clinical characteristics must be similar to the extent that there is no clinically significant difference in the safety and clinical performance of the relevant device.
Expert advice
At Boyds, we understand how important it is for patients to have access to the latest medical technologies available, and we will be keeping an eye out for any further updates to the MHRA’s latest steps. Contact us today to find out more.