The anticipation of new medical device-related regulations in the UK has led to some concerns that additional premarket clinical or postmarket surveillance data would be overly burdensome.
As GlobalData found, the additional data to satisfy regulators will be a significant challenge for smaller in vitro diagnostics (IVD) manufacturers whose market is essentially only in the EU, says Andrew S. Thompson, PhD, director of therapy research & analysis at GlobalData.
However, the requirement for additional clinical data is not that big a shock to most device manufacturers, says Eamonn McGowran, associate director for Regulatory Affairs at Boyds Consultants.
The UK’s exit from the EU has meant the area is not beholden to the new European Medical Devices Regulation (mDR) which has replaced the current Medical Devices Directive (MDD). UK law still relies on the less-rigorous MDD as the basis for medical device marketing rules. Thus, neither the MDR nor companion rules like the In Vitro Diagnostics Regulation (IVDR) will have a direct effect on the availability of medical devices in the UK.
The EU MDR and IVDR regulations became effective May 2017 but to allow time for companies to acclimate to the new requirements, the regulations became applicable over a transition period. The MDR had originally provided a three-year transition period (becoming operational May 2020), however, due to COVID-19, full application of the MDR had an extended timeline of 26 May 2021. Similarly, the IVDR will be fully applicable on 26 May 2022, after a five-year transition period.
But because of significant delays in the IVD sector adjusting to the regulation, the Europeans published a proposal to postpone the full application deadline, and a final decision by the European Parliament is pending.
At some point, the UK will also likely introduce new medical device regulations, based on the findings of the so-called Cumberlege Review, which reviewed the harmful effects of some therapies and devices on female health, says Thompson. The British government is likely to continue to consult with medical device stakeholders such as manufacturers, healthcare providers and patient advocacy groups, to develop these new regulations.
“The UK has always had a strong role in device development and regulation,” McGowran says. Amendments to create the new regime are scheduled to be in force at the beginning of July 2023. This will align with the date from which the UK is due to stop accepting CE-marked medical devices in Great Britain and will require the use of the UKCA marking (1 July 2023).
The EU MDR has brought regulatory requirements for devices to a higher standard and as a result, some of the risk classification previously used for devices has changed, explained McGowran. It would seem the UK could likewise raise the standards in its own consultation process. “The UK is unlikely to exist in its own regulatory bubble,” Thompson says.
We review the potential industry impact.
Clinical trial ramp-ups
For example, a device reclassified as Class II or Class III would have to undertake appropriate clinical investigation, McGowran says. Likewise, a legacy device that was approved under older rules might now lack adequate clinical data to stay on the market. “The onus falls on the manufacturer to justify the clinical data is sufficient.” This can take the form of new clinical studies or greater postmarket assessments, he says.
Few European IVD SMEs have experience conducting clinical studies for devices unless they are also marketing them in the US. This is reflected in a general lack of IVD experience by European CROs, Thompson says. But IVD makers do conduct performance evaluation studies, McGowran says.
In terms of impact on the industry, The British Standards Institution, an accredited certification body, says there are concerns about the timelines of the yet-to-be-published UK Medical Device Regulation. The timeframe to draft, approve and publish legislation by 2023 is very tight and many stakeholders share concerns about that, according to a spokeswoman.
“The timeline issues are exacerbated by the parallel challenge for both manufacturers and UK Conformity Assessment (UKCA) bodies to meet the impending deadline for the end of the transition period for the EU MDR, in May 2024.”
Potential negative downturn for IVD makers
Not all device companies will have the internal financial resources to conduct such clinical studies or further postmarket reviews, McGowran says. Though larger CROs will be capable of such work. ICON and LABCORP are two such service providers well-versed in device studies, he says.
Ultimately though companies will have to question whether the additional resources make sense in terms of the market potential. The UK market is much smaller than the EU so it could mean that companies may turn away from the British domain to focus on changes in the EU regulations.
“The uncertainty about the new regulations may reduce appetite for the UK market,” Thompson says. “The recent report in device safety identified ways in which the MDR could be strengthened. The challenge is whether all of these can or will be implemented.”
There was a steady increase in EU IVD trials activity until 2020, according to GlobalData’s Medical Intelligence Centre. “As healthcare systems recover, expect more focus on new diagnostics, and particularly those in non-healthcare settings such as the home,” Thompson says. “This will require innovative technologies to bring laboratory-grade tests out of the testing centres.”
MedTech Europe, the European trade association of the medical technology industries, noted in a December 2021 press release that at least one outstanding issue is the capacity of IVDR-notified bodies. This minimal capacity is a huge issue; the change in regulations resulted in many bodies choosing to exit the market, rather than recertifying.
This recertification requirement is largely why the IVDR rollout is likely to be delayed, or phased, Thompson says. The expected exit from the market is something that will be particular to IVD; smaller companies will exit, and license technologies and products to bigger multinational players, he adds.
“The lack of notified bodies will not only create bottlenecks in getting new devices onto the market, but also affect how companies can market existing devices.” He cites Smiths Medical, a major provider of medical devices as an example.
In 2018, Smiths had to suspend sales of some devices in Europe due to its Notified Body losing the certification to issue CE marks. Still, the European proposal does include additional transition periods for devices that need to undergo conformity assessment by Notified Bodies for the first time under the IVDR.