MHRA to move forward with medical device reliance plans
The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to propose an indefinite recognition of CE-marked medical devices and new pathways to get devices on the market that have already been vetted by Australia, Canada, and the US later this year. The announcement is part of the agency's efforts to use international reliance to regulate products while reducing its administrative burdens.On 22 July, MHRA announced it had reviewed feedback from stakeholders on its proposal from May 2024 to help medical devices get to market faster. More specifically, the agency proposed allowing products to access the UK market if they are already authorized in comparable regulator countries (CRCs) such as Australia, Canada, the EU, and the US. Having reviewed the feedback, the agency says it will move forward with its proposal. (RELATED: MHRA proposes recognition path for devices cleared by trusted regulators, Regulatory Focus 21 May 2024)
“As well as improving patient access to technologies, the proposals will boost med tech industrial growth by reducing duplicative regulatory costs faced by manufacturers and instead focuses the domestic approvals route (UKCA) on first-in-market innovative technologies, including AI as a medical device,” said MHRA.
“The MHRA will support removing the requirement for physical UKCA markings on products and packaging once unique device identification (UDI) requirements are in place,” the agency added. “This will reduce barriers to entry to the market while strengthening traceability and safety monitoring.”
MHRA said that using international reliance will allow medical devices that have approvals or certifications from CRCs to provide a more streamlined pathway to market and includes certain software and implantable devices that meet its equivalence criteria.
“The government will consult later this year on proposals to indefinitely recognize CE marked medical devices, which continue to be recognized in [Great Britain (GB)] under existing transitional arrangements until 30 June 2028 or 2030 (depending on the device classification and legislation complied with),” said MHRA.
“Class B IVD devices will be subject to a more risk proportionate approach, requiring manufacturers to self-declare conformity with the Medical Devices Regulations 2002 and hold ISO 13485 quality management system certification before placing products on the GB market,” the agency added.
MHRA’s announcement is in line with its stated commitments in the UK’s Life Sciences Sector Plan and Industrial Strategy and the 10-Year Health Plan for England. Broadly, the commitments are intended to reduce the agency's administrative burdens, considering its limited resources, especially after it left the European Union under Brexit. (RELATED: MHRA details plans for future medical device, IVD regulations, Regulatory Focus 10 January 2025)
“Today’s announcement forms part of our broader regulatory reform program for medical devices that will see improvements in patient safety through our new post-market surveillance requirements, the creation of streamlined and risk-proportionate routes for faster market entry for products that have already undergone assessment in comparator regions, and a refocusing of the UKCA domestic pathway on innovative technologies including AI,” said MHRA CEO Lawrence Tallon.
MHRA’s announcement also echoes its plan to update its regulations for certain high-risk in vitro diagnostics (IVDs). More specifically, it proposed using common specification requirements to evaluate certain Class D IVDs, so they are consistent with European regulations, particularly EU Commission Implementing Regulation 2022/1107. It also proposed requiring the use of common specification requirements in a Post Market Performance Follow-up (PMPF) Plan and ending the Coronavirus Test Device Approval (CTDA) process to prevent duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements and reduce burdens on test manufacturers. (Related: MHRA plans to align with EU common specifications for high-risk IVDs, Regulatory Focus 14 July 2025)
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