Need to know:
- Covid-19 caused the implementation of the new EU Medical Device Regulation (MDR) to be delayed by 12 months to May 2021.
- In the UK, new devices must conform to the UK MDR 2002, the EU MDR (until 2023), or the EU In Vitro Diagnostic Regulation (IVDR) (until 2023) in order to be registered with the MHRA. However, while IVDR is due to be implemented for new devices in the EU from May 2023, it is likely to be delayed due to a shortage of notified bodies. Therefore, it’s uncertain whether new in vitro diagnostic (IVD) devices entering the UK will ever be subject to IVDR for UK marketing. Currently, the legal requirements for the UK are based on the IVD Directive. Manufacturers can already use the IVDR to obtain approval.
- Existing devices will remain on the EU market until their CE certificates expire. Then they will need to recertify using the new regulations or take the device off the market. Certificates are generally issued for three years, but for some high-risk devices, this is as short as one year. CE marks will be recognised in the UK until January 2023, at which point manufacturers are expected to comply with the new UKCA compliance marking.
- The UK will introduce a new medical device regulation, based on the findings of the Cumberlege Review, which looked at the harmful effects of some medicines and medical devices on female health.
- If the UK fully takes up recommendations in the Cumberlege Review and adopts the minimal standards of the MDR and IVDR, the UK’s medical device regulatory landscape could end up more stringent than the EU’s.
The year 2020 proved to be a momentous year for medical devices regulation in the UK. In May, there was widespread anticipation around the implementation of the new European Medical Devices Regulation (MDR), replacing the old Medical Devices Directive (MDD). During July 2020, member of parliament Baroness Cumberlege concluded the Independent Medicines and Medical Devices Safety Review, AKA the Cumberlege Review, which looked at the harmful effects of some medicines and medical devices on female health.
On 31 January 2020, the UK formally left the EU, entering a transition or implementation period, designed to soften the impact on business and give the UK and EU the space to conclude future trading relationship arrangements. Around the same time, there was the emergence of a new respiratory disease in China that was to greatly impact the rest of the world.
In 2020, the existing European directives relating to non-IVD medical devices were intended to be replaced by the MDR. This change, planned for May that year, was intended to also pass into British law at the same time – ensuring a smooth passage for medical devices.
Covid-19 caused this implementation to be delayed by 12 months to May 2021. The delay put implementation of the MDR outside of the transition period, so this regulation will not be implemented into UK law as it stands.
While the EU is now fully implementing the MDR, UK law still allows the lesser MDD to be the basis of medical device marketing rules. Thus, neither the MDR nor the sister regulation, the In Vitro Diagnostics Regulation (IVDR), which was due to be implemented from May 2022, will have a direct effect on the availability of medical devices in the UK.
New medical devices entering the UK market will only need to comply with the former and, for some, less stringent device standard, which was embodied in the MDD and forms part of British law. The UK has continued to recognise devices that are complying with MDR for the purposes of marketing, but at the same time will also accept devices conforming to a different standard. The Medicines and Healthcare products Regulatory Agency (MHRA) has become the gatekeeper of all new medical device registrations.
At some point, the UK will introduce a new medical device regulation, based on the findings of the Cumberlege Review, and following consultation with medical device stakeholders such as manufacturers, healthcare providers and patient advocacy groups. How this new regulation will be implemented is not clear, nor is it clear if there will be a transition period for new devices conforming to the older standard.
The review made several recommendations as to how UK regulation can be strengthened, some of which the UK Government has made a preliminary acceptance. However, the final changes to the regulations will also accommodate the inputs of other healthcare and regulatory stakeholders following consultation.
It is likely that the new regulations will go some way further than the European MDR, but it is possible the UK Government will seek to devise mechanisms that will mitigate impacts on the medical devices industry, without sacrificing safety.
The clock is ticking
By June 2023, existing CE certificates will no longer be recognised in the UK, so new regulation must be in place and implemented before then.
The Cumberlege Review makes brief reference to the MDR and, by extension, the IVDR, by stating it assumes “the most stringent measures” will be implemented by the UK Government. However, the review goes on to recommend that there are further measures that can be implemented by the UK to ensure patient safety, in particular publicly accessible adverse event reporting databases, which is something that has been resisted by EU member states as part of the MDR.
If the recommendations of the Cumberlege Review are fully taken up along with the UK adopting the minimal standards of the MDR and IVDR, this may potentially result in a new UK medical devices regulatory landscape that is more stringent than the EU’s. GlobalData’s Device Approval Analyzer estimates, based on an analysis of over 10 years of historic data, that devices in the European Union, under the old directive’s regime, would reach the market over two years before those intended for the US market.
The MDR has not been universally welcomed by the industry, and there have been fears expressed by industry bodies that the regulation may stifle innovation. It has been pointed out that, historically, new medical devices would reach European patients seven years before those in the US market regulated by the FDA.
The cornerstone of the new regulation is that, in its very wording, it promises to provide EU citizens with the safest and most advanced medical devices available. The Cumberlege Review suggests the regulation could go further on the latter point.
The impact of Covid-19 on regulation rollout
For the implementation of the MDR, Covid-19 has been troublesome. This is due to a chronic shortage of notified bodies, such as the TuV and BSI, the auditing organisations who are the lynchpin for a device to receive the all-important CE certification necessary for marketing within the EU.
The transition from Directive to Regulation has resulted in many of these bodies either struggling to recertify for the new regulation or simply leaving the market. While the IVDR implementation has suffered under the Covid-19-induced delay that applied to the MDR, the EU is proposing, at this late hour, a delayed rollout. It suggests phased launches for different classes of IVD tests because of the lack of accredited notified bodies.
There have already been suggestions in the regulatory industry that the IVDR may cause some smaller players – faced with increased costs, particularly in relation to clinical trials – to simply exit the market, leading to increased market share for major players such as Siemens Healthineers, Abbott Laboratories and Thermo Fisher.
Covid-19 will leave a lasting mark on the UK medical devices regulatory landscape, introducing the potential for the UK to diverge from European standards at an early point following the end of the Brexit transition period.
The UK Government has responded to the Cumberlege Review through the Medicines and Medical Devices Act 2021, and the expansion of the role of the MHRA in the regulation and registration of medical devices placed on the UK market. Importantly, the government will implement a public database of reportable adverse events.
However, in its response to the review, the UK Government noted that there was a desire that, for any new regulation, “the UK remains an attractive place to develop and introduce medical devices so that patients have access to safe products”. As the new regulations are discussed and fleshed out over the coming year, there will undoubtedly be debate on the fine line between ensuring patient safety and encouraging the innovation of game-changing medical device technologies.