Consultation Details and Scope
The consultation, formally launched on 16 February and set to conclude on 10 April 2026, focuses on eliminating the time limits for accepting devices certified under the EU’s contemporary regulations: the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This action acknowledges the reality that, despite the introduction of the domestic UKCA marking, the vast majority, approximately 90% of medical devices currently on the GB market still bear the EU CE mark.
Prior to this proposal, these CE-marked devices were permitted to remain on the market under transitional arrangements until the expiration of their certificate or a hard statutory deadline, currently set for 30 June 2030. The MHRA’s move to remove this deadline is a direct response to industry calls and a clear attempt to safeguard the supply of critical medical products to the National Health Service (NHS) and patients across Great Britain.
Three Key Consultation Areas
The MHRA is soliciting feedback on three distinct but interconnected areas. Firstly, the central proposal involves allowing devices that comply with the rigorous standards of the EU MDR and IVDR to be placed on the GB market without any defined end-date. This would effectively align Great Britain’s acceptance of these products with the longstanding practice of mutual recognition within the EU single market, offering a simpler, more predictable regulatory path for manufacturers.
Secondly, the consultation addresses the issue of older devices. It proposes aligning timelines for devices certified under the previous, less stringent EU Directives (the Medical Devices Directive, Active Implantable Medical Devices Directive, and In Vitro Diagnostic Medical Devices Directive). This step is strategically designed to prevent a wave of simultaneous product withdrawals or certification bottlenecks, thereby mitigating the risk of critical supply disruption as the existing deadlines approach.
Thirdly, the MHRA is exploring the introduction of limited International Reliance Routes. This would apply specifically to certain higher-risk, CE-marked devices. This initiative suggests a willingness to leverage the regulatory oversight of other trusted international jurisdictions, streamlining the process for getting essential, high-quality devices to the GB market more quickly, provided they meet the high safety and performance standards demanded by the MHRA.
Rationale: Pragmatism and Supply Resilience
The rationale underpinning this significant policy shift is rooted in pragmatism and a commitment to supply resilience. Lawrence Tallon, the MHRA Chief Executive, explicitly stated that the long-term recognition of the CE mark was the "number one request" from the medical device industry. He emphasised that the proposed reforms are strategically aimed at supporting supply chain resilience and ensuring continuous patient access to innovative and essential medical technologies.
Industry Reaction and Anticipated Benefits
The industry’s reaction has been overwhelmingly positive. Stakeholders view the proposal as a long-awaited and necessary step towards regulatory clarity, stability, and predictability. Indefinite recognition is expected to deliver multiple benefits. It will fundamentally simplify regulatory planning for companies operating across the EU and UK. It is anticipated to significantly reduce compliance costs by eliminating the necessity for manufacturers to pursue costly and time-consuming dual certifications, both the EU CE mark and the UKCA mark for the GB market. Furthermore, by removing a major regulatory hurdle, the move is projected to enhance the UK’s overall market attractiveness to international manufacturers, encouraging global companies to continue prioritising the GB market. Most critically, it secures supply continuity by preempting the severe potential bottlenecks and shortages that could arise if a large number of certificates were to expire simultaneously around the current 2030 deadline.
Critiques and the Future of UKCA
While the proposal enjoys broad approval, it is not without its critics. Some caution about the potential long-term consequences of this policy, specifically the risk of regulatory divergence between Great Britain and the European Union. They argue that a permanent reliance on the EU's regulatory apparatus may hinder the development of an independent, responsive, and innovative domestic UK regulatory system. These critics also stress the continued importance of the UKCA regime, particularly for the oversight and certification of cutting-edge technologies like AI-enabled medical devices, where the UK has a stated ambition to lead.
Implementation Timeline
The consultation forms a central pillar of the MHRA’s broader regulatory reform programme. This programme is designed with the overarching goal of establishing a medical device regime in Great Britain that is risk-proportionate, aggressively pro-innovation, and fundamentally patient-focused. By dismantling significant regulatory hurdles, the indefinite recognition framework directly supports the government's wider ambition to cement the UK's position as a global leader in the life sciences sector. Following the closure of the consultation in April 2026, the MHRA is committed to a thorough review of all submitted responses, with the final framework anticipated to be implemented later that year, ensuring it is firmly in place well ahead of the current transitional deadlines. This proactive policy decision is set to define the regulatory landscape for medical devices in Great Britain for the foreseeable future.
