Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic devices’

Key takeaways:

• EU Assimilated Laws: MHRA will extend the sunset period on four key EU-derived regulations beyond 26 May 2025 to prevent disruption until new UK-specific laws are established. The retained regulations cover IVDs, electronic instructions, animal tissue devices, and approved bodies. Manufacturers will benefit from regulatory stability but need to prepare for future changes. Health care providers and patients will experience continued access to devices.
• International Reliance: MHRA plans to rely on approvals from Australia, Canada, EU, and US, given their comparable regulatory systems. MHRA will implement three routes to market; routes 1, 3, and 4 set out in the consultation. Route 4 will be expanded to include software as a medical device and implantable Class IIb and III devices that comply with US 510(k) legislation. These routes broadly cover the following devices:
  • Low risk devices and active devices that comply with device legislation in Australia, Canada, EU and US;
  • Non-active devices that comply with device legislations in Australia, Canada and US;
  • Class IIa, IIb (non-implantable) and IIb non-resorbable sutures, staples, dental, fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors that comply with 510(k) legislation in the US;
  • Medical devices that incorporate an ancillary medicinal substance from Australia, Canada or US; and
  • Class D IVD devices that comply with device legislation in Australia, Canada and US.

Other than Route 1 (covering low-risk devices), CE marked devices won’t be included in these routes to market, until further consultation on the indefinite extension of the CE-mark is completed. Route 2, which covers non-active devices from EU, will also not be implemented at this time, and until the CE-mark consultation has completed.

• IVDs: MHRA will implement a risk-based approach for IVD devices in line with the position in the consultation, and will amend conformity assessment requirements for Class B IVDs to require UKCA self-assessment and QMS certification to ISO 13485. Certification from UKAS or IAF accredited bodies will be accepted, with a transition period provided. The classification system will shift to a risk-based framework to better reflect health risks; with four classes (A-D), aligning with the principles of the International Medical Device Regulators Forum. The aim is to enhance patient safety while reducing burdens on low-risk devices. Manufacturers will have five years to comply with these changes to ensure a smooth transition.
• UKCA Marking: The requirement for UKCA marking will be removed, conditional on the implementation of Unique Device Identification (UDI) for traceability. This change will occur once the UDI database is operational. There will be a transitional period of three years for general devices and five years for IVDs for UDI compliance.

With the slew of regulatory changes coming up, manufacturers have an opportunity to consider longer-term global regulatory strategies, perform wider audit checks across QMS systems and compliance frameworks for alignment with the UK medical device regulations.

Authored by Jane Summerfield, Bonella Ramsay, and Alexandra Wood.