In January, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that the post-market surveillance (PMS) statutory instrument for Great Britain will come into force in June. PMS is the first medtech SI with pan-industry scope after Brexit prompted the need for a sovereign regulatory system for Great Britain.
During the Association of British HealthTech Industries’ 2024 annual conference, Laura Squire, as MHRA lead for device system regulatory reform, likened PMS to a seatbelt that allows the devices sector to move faster. Steve Lee, ABHI diagnostics and digital regulation director, said the PMS “seatbelt” would enhance safety.
Next to come will be the pre-market SI, expected in 2026. But it will not be steered by Squire, who left the agency MHRA and her main role as chief healthcare quality and access officer on 31 January to take up a role unrelated to regulatory work. This ostensibly leaves MHRA without a senior device champion at the agency, a situation that Lee and fellow ABHI regulatory and technical director Phil Brown will monitor closely.
PMS ‘Central To Everything’
PMS will be seen as the foundation and basis of the evolving British system – whether or not the system continues to employ physical UKCA marking, what the rules may be for allowing CE-marked devices continued access the market, and how the agency manages the introduction of devices from trusted overseas regulators in Comparable Regulatory Countries (CRC), under the system of reliance.
Squire told ABHI delegates in 2024: “Everything on the UK market has to be subject to PMS.”
For Brown, the PMS SI is a good framework that will be filled out by guidance. Unlike the EU Medical Device Regulation, which has consolidated pre-market and PMS rules in a single regulation, the British system will have separate SIs, such that one could use one without the other, he observed.
“Reliance can be matched against PMS, and this could be a good way of introducing innovation into the UK,” Brown said.
British PMS is more stringent than EU PMS, and in the wake of the IMMDS review (the Cumberlege report) on patient safety, the UK has focused on factoring in the patient viewpoint. The ABHI directors says they will hold the forthcoming PMS guidance up against EU PMS to identify the differences. Incident reporting timescales (two, 10, 15 days) are the same in the EU and Great Britain, they note.
Crucially, Great Britain’s medtech regulation is aligning itself more, in its embryonic stages, with International Medical Device Regulators Forum (IMDRF) principles. Pursuing this path is designed to give the MHRA a global PMS perspective on the performance of devices, not just an EU-UK perspective, Lee added.
But cost could be a disincentive, he said. The PMS’s impact assessment suggests a combined annual cost of £30m ($38m) for device companies serving the British market.
MHRA Fees ‘Need A Rethink’
This will come on top of a new scale of fees to be charged by the MHRA as of April 2025. The new fees will add a further £16.5m per year to the device industry’s UK market access costs. The fee proposals went out for consultation in autumn 2024.
“Fees were not the way to go.”
Steve Lee
Lee said: “Our feeling about the fees is there is a lot of disquiet in industry, especially among ABHI members companies. Fees were not the right way to go. There is no added value in the £16.5m being asked, merely the same level of service being delivered with very high increases. These are hard to justify.”
ABHI is in favor of the government pausing the charges. The new fee of £210 per GMDN code per year held by companies will be overly burdensome to producers of, for example, IVDs, surgical instruments and wound care product ranges that require multiple GMDN codes. The change in 2025 implies a massive rise in their annual costs.
The fee schedule seems to unfairly penalize companies that have larger ranges of products. The MHRA has also hiked the charge for accrediting approved bodies at a rate far above UK inflation. Approved bodies will doubtless charge higher fees to industry as a consequence.
Brown pointed out that MHRA will charge £1,000 for a one-hour pre-submission meeting with a manufacturer. The current pre-submission offer is not a well advertised service, he added, noting that the pre-submission advice from the US Food and Drug Administration (FDA) is offered free-of-charge.
2024 Consultation
The MHRA consulted stakeholders in late 2024 on a range of issues that were not covered in its 2021 consultation. It asked, among other things, how Great Britain should classify IVDs in view of the move towards IMDRF-based regulation
Elsewhere, ABHI identified three main themes on industry’s agenda:
- The need for a UK regulatory framework (not necessarily anchored by a physical UKCA marking), that encourages innovation and early access;
- Indefinite and continued recognition of the CE marking to help maintain existing supply chains – as has already been seen in other sectors of industry in Great Britain; and
- Streamlined reliance regarding devices already approved by the four existing CRCs (EU, US,* Australia, Canada), possibly augmented by Japan at a late date.
*Initially there were concerns in MHRA circles about the safety of 510ks based on certain historical scares, usually involving implants. But ABHI notes how the FDA has “upped its game” on 510ks, and that it now uses many fewer older predicates, while asking for a lot more clinical evidence in 510ks. “It’s a substantially different beast than what it was a few years ago,” Lee said.
“What value is a UKCA marking if companies also want to go elsewhere with their products?”
Phil Brown
The use of CRCs will not be a reciprocal arrangement, but the strength of UK PMS might be used in future to strengthen then UK’s position and arguments for securing some form of reciprocity of regulatory approvals, Brown said.
He supports the widespread industry view that allowing indefinite CE marking in the UK would negate the need for UKCA markings in Great Britain. “What value can a UKCA marking deliver if companies also want to go elsewhere with their products?” he asked.
However, a national Great Britain regulatory scheme would lend itself to other jurisdictions recognizing the UK, the ABHI directors added.
MHRA tools such as the Innovative Devices Access Pathway (IDAP) and the AI Sandbox are good examples of the agency being proactive about innovation, said Lee. The sector awaits initial outputs from the five-company AI sandbox pilot launched in 2024.
Similarly, there is no sign of a second round of applications for IDAP, in the wake of the eight-company first intake last year. “It could be much more ambitious,” Lee said. “ABHI is supportive of IDAP, but feels the system could be more transparent. The real test will be if these products actually make a difference to patients’ lives.”
MHRA To Respond
The MHRA will respond to the 2024 consultation in early summer 2025 (possibly as early as April). Its responses should be factored into its work to build the premarket SI.
The finalized document should go out for World Trade Organization review, and be back with the UK parliament by the end the year.
A further six-month period for implementation is planned before the mid-2026 in-effect date.
Work To Be Done
Lee said the stakes were high for UK medtech, and issued a warning to the MHRA and UK medtech stakeholders.
He said: “Without an effective UK system supporting innovation and early patient access or continued indefinite recognition of EU CE marking, and with only a checkbox approach to international reliance, the MHRA would risk both the UK’s position as a global healthtech leader and undermining improved health outcomes for patients.”
He added: “The UK healthtech sector stands poised to address an increasingly competitive global landscape. The MHRA must now do the same.”
These sentiments are encapsulated in a six-page call to action issued by ABHI in late January, entitled “HealthTech Regulations: Driving Economic Growth And Ensuring Patient Safety.”
With Laura Squire no longer in place at the agency as medtech regulatory reform lead, there is certainly a lot of work to be done at the MHRA, the ABHI directors said. “MHRA needs to be resourced for healthtech and for the regulations.”
The ABHI asks how the agency will achieve that, and wants to know how it plans to address the gap left by Squire’s departure.
These questions are top of mind for the industry association. Others are: Will there be any MHRA board representation for devices in the future? How should industry promote devices within the agency now? And can someone be appointed at the MHRA to drive forward device regulatory reform?
Squire’s leaving follows the announced departure of June Raine, who last year said she was to step down as agency chief executive. Chairman Stephen Lightfoot left in 2023.
Lee suggested MHRA might aim to put a new leadership system in place before considering the organization’s structure. “It’s a reset for everything, potentially,” he said.
Brown observed that Squire focused on and championed devices. She was involved in a lot of projects for devices and IVDs, he noted. “It’s a challenge when new people come in. One of the things ABHI must do is get in front of the new chair and CEO when they arrive to establish relationships again,” he said.
On the ABHI’s more immediate priority list is to take part in discussions around the PMS guidelines. “The No. 1 need we see now is supporting members on the practical implications of PMS, whilst also supporting MHRA in their implementation of the new rules and guidelines,” Brown said.
