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Guidance on high level regulatory requirements for medical device and diagnostics companies entering and selling in Great Britain and Northern Ireland has been issued to help them navigate a route onto the local markets after the UK’s final transition of out of the EU.

But the level guidance so far from the Medicines and Healthcare products Regulatory Authority (MHRA) has left the industry hungry for more, and specifically on the requirements for product registrations when the UKCA marking for the Great Britain market becomes mandatory in mid-2023.

Steve Lee, the newly-appointed head of diagnostics regulation at the Association of British HealthTech Industries (ABHI), said association members and the wider industry are keen to have this detail. “It’s the kind of forward-thinking we need to see” from the MHRA, and “the sooner we get it, the better,” he told Medtech Insight. (Also see "MHRA’s Lee To Give UK Medtech Industry Greater Diagnostics Focus" - Medtech Insight, 14 Sep, 2020.)

The need to pre-plan for the UKCA marking could not come at a busier time for UK companies and indeed those in the EU27 and beyond who service the UK’s medtech markets. And in the diagnostics industry, companies are intensely focused on COVID-19, which in turn has thrown the spotlight back onto diagnostics regulation, said Lee.

Bigger still for IVDs players over the longer-term is the need for compliance with the EU In Vitro Diagnostic Regulation. The shift from the IVD Directive to the IVD Regulation is “massive,” said Lee. EU notified body involvement under the IVDR might be necessary for as much as 95% of IVD product files overall, he speculated. For some companies, it will be 100% of their portfolio. 

Companies working in the UK in the post-EU phase must factor in the provisions of the new UK Medicines and Medical Devices (MMD) bill – the Brexit bill  ̶  once it becomes law. “A whole lot of discussion is needed around MMD bill and what regulatory framework we are looking for in the UK,” said Lee. (Also see "‘MDD+’ For The UK, As Future Devices Regulation Will Be A ‘Living Document’" - Medtech Insight, 9 Oct, 2020.)

Whether the MMD Act and its ensuing secondary legislation will be aligned to any extent to the future IVDR, which comes into force in the EU27 on 26 May 2022, depends on the political will of the UK. The regulation will be enforced in full one year exactly after the EU Medical Device Regulation is enforced. Neither regulation will be retained UK legislation, post-Brexit.

Lee joined the ABHI in September to widen the association’s remit to IVDs in view of the critically important regulatory changes ahead for diagnostics companies. He said the MMD legislation will impact IVDs and devices equally. The bill has been in the House of Lords’ Committee Stage since 18 October, where another debating session is scheduled for 11 November.

The IVD industry is working on very short timescales for potentially large changes. “Everybody wants more certainty than we’ve got,” said Lee. But benefits from the new legislation should emerge eventually. “It’s an opportunity to get a regulatory framework that fits the UK,” he said, adding that local regulation might also be shaped by global mechanisms, such as the Medical Device Single Audit Program (MDSAP).

UK approved body/notified bodies for IVDs number just three companies at present. Whether that will be enough capacity to handle all future UK files depends on demand, which is as yet unknown. For the EU27 market, only four notified bodies have so far been designated against the IVDR – and one product so far designated under it (in late October).

Lee hopes there will be an extra push to get more EU IVD notified bodies “across the line” before the May 2022 deadline. Nevertheless, he views a deferment of one year, as happened for the MDR, as wise to consider, if seen through the lens of cost in terms of patient safety and public health; and cost to industry. The benefits of such a postponement should be clearly identified, he stressed.

There is a case for a more nuanced discussion on this, Lee suggested. It should take as its lead question the theme of “what parts of the IVDR need to happen immediately, and what parts can wait, if they do not affect patient safety or public health.” The process would start with open discussions in EU circles. On an industry level, the ABHI will remain a member of the industry association, MedTech Europe. 

Impact Of New Regulations On IVD Innovation

Not all innovation is new technology, materials or manufacturing processes; it can also be new intended purposes that address unmet clinical needs. The latter are likely to present a high risk-benefit profile. And this can be potentially useful to companies seeking to develop innovation under the perceived higher costs of compliance with the IVDR, say.

A life cycle approach to innovation, where companies work in a “safe space” to innovate, ie where the patient safety/public health risk is properly managed, is one option for ensuring innovation flows in times of increased regulatory hurdles, said Lee. 

“Regulation should not be seen as a barrier, but rather as a route map” for IVD and device companies alike, said Lee. He prefers to see the issue as how regulations can help companies get to market.

Procurement Systems Remain Suboptimal

Nevertheless, there remains a gap between market authorizations and procurement, a fact that that has long frustrated Lee, including during his 24-year career at the MHRA. Bridging that gap is a crucial, he said.

At the start of COVID-19, the MHRA developed target product profiles (TPPs) for products used for pandemic control purposes, including clinical effectiveness and clinical utility criteria. Such an initiative could help close the gap in non-COVID times too, Lee suggested.

The richer the clinical evidence presented for products being brought through the marketing authorization process, the lower should be the need for de novo health technology assessment (HTA) information.

The current system is not straightforward and is duplicative, said Lee, but the UK has an opportunity to streamline it by creating a much clearer handover from market authorization to HTA, thereby making it easier for companies to navigate the system.

Many positive developments have, implausibly, emerged from the pandemic. One is the readiness of individuals and organizations to work together. Patient centricity was the motivating factor for the positive collaborations seen during COVID-19, said Lee. “We hope to see some of that continue, going forward.”

Lee’s overriding aim is to build a regulatory strategy for IVD companies in the UK – ABHI members in particular – that takes forward the existing dialog between the industry and the MHRA. “We must focus on the positives that we, the industry, can develop,” he said.


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