With Brexit being a reality, and countries still fighting the COVID-19 aftermath, the UK government works intensively on the future of its regulatory regime, which is yet to be unveiled.
We all know the UK did not implement the EU MDR, fully applicable as of 26 May 2021 across the European Union, but this does not mean that the MHRA has not been developing plans to make a name out of the upcoming new UK medical devices regulatory regime.
The UK aims at eventually establishing a world-leading regulatory environment and, thanks to the recently published MHRA Delivery Plan 2021-2023, we can check its first hints.
Main nuances of the upcoming UK medical devices regulatory regime
Although it still lacks the substance, the regime is starting to deploy some of its main features, which are worth mentioning for the benefit of stakeholders:
- New legislation is expected and already on the way: the MHRA will design, consult on and implement a new legislative framework for medical devices;
- 2022 and 2023 are the key years: in the upcoming years, the MHRA will firstly publish a public consultation covering all key aspects of a proposed market access framework; secondly lay the relevant statutory instruments down; and subsequently key guidance documents. Lastly, the MHRA intends to publish a consultation on ensuring an integrated UK regulatory pathway for products that combine medicinal products and medical devices;
- Multi-input: the MHRA is working hand in hand with its partners across the healthcare sector for the design and implementation of the new regime. It is hence trying to get everyone involved in the process from the very beginning.;
- Safety surveillance and risk management: the MHRA sets the focus on the delivery of a more responsive safety surveillance and risk management system for all medical devices – this being pretty much like the pro-active approach the EU MDR took on this topic. The UK expects to be embedding a template, as well as identifying opportunities for patient involvement by the end of 2022.
In the same line as the above main takeaways from the Delivery Plan, the Regulatory Horizons Council of 19 August 2021 issued the following recommendations via its report.
Risks identified recommendations of the Regulatory Horizons Council of 19 August 2021
Technology is ground breaking, it always has been and always will be. As a matter of fact, the genuine digitalization we experience on almost every aspect of our lives is urging the law to try and adapt as quickly as it can. In the UK, things are no different.
Following Brexit, the UK is now busy working on its personal ‘new regulatory era’, for which the Regulatory Horizons Council, held on 19 August 2021, issued a series of recommendations after addressing some identified risks.
Goals of the new regime:
- Ensuing the continuity of medical devices’ availability to the UK citizens;
- Improving the safety of medical devices.;
- Creating a landscape that is fit-for-purpose for new forms of devices, such as Artificial Intelligence as a Medical Device.
- Risk to the patients’ safety and reduced access to devices, arising from lack of capacity in approved bodies within the UK;
- Risk of reduced competitiveness of UK device manufacturers. This is arising from: (1) delays in awaiting the conformity assessment, due to the lack of capacity of UK approved bodies, and (2) increased costs arising from the need to seek separate regulatory approval in the EU, if the manufacturer wishes to continue exporting to the European market.
- The threat of regulatory divergence. New barriers to regulatory approvals for imports and exports?
- Imported devices: there is a high risk for patients losing access to certain devices after the ‘hard-stop’ of 30 June 2023;
- UK manufactured devices for export: additional costs that will incur to achieve the CE conformity assessment in addition to the UKCA mark;
- Northern Ireland: stakeholders are considering relocating their businesses to Northern Ireland. This enables them to take advantage of the opportunity of parallel regulatory pathways available to them.
- The need for certainty, clarity and guidance through the changing regulatory landscape. It is common understanding that there is a need for greater clarity in the regulatory pathways for different types of devices.
Regulatory Horizons Council Recommendations:
- The regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients and provide evaluations that are understandable to patients;
- Strengthen and increase funding to the MHRA in order to significantly expand their capacity in medical devices, including in the domain of emerging technologies;
- Address bottlenecks in the approval of medical devices, notably the shortage of UK approved bodies (ABs) for conformity assessment;
- Prepare mitigations that supplement AB capacity to ensure supply of devices after transition to UKCA. This can be achieved through the following: • Maintaining the 1 July 2023 deadline for some devices, but considering extending it for others • Considering assurance or reliance routes or mutual recognition of devices;
- Support the MHRA to increase UK visibility, international engagement and leadership;
- Invest in the UK as a global centre for regulatory science and in the training of regulatory professionals with expertise in medical devices, including in relation to emerging technologies;
- Build international partnerships through mutual recognition and reliance or assurance, where this may lead to overall efficiencies, whilst preserving safety;
- Identify and resource areas where regulatory innovation within the medical device sector may attract inward investment and growth;
- Develop a UK patient safety database that collects key details of all medical devices and monitors patient safety and wellbeing moving forward
- Strengthen existing safety reporting through digital tools and the use of comprehensive data collection from health systems, patients and carers to a central MHRA-held UK Patient Safety Database.
- When medical devices are used, their unique device identifier (UDI) should be recorded as standard within a patient’s health record, and this should be returned to a central MHRA-led UK Patient Safety Database;
- Pandemic preparedness should include fast-track evaluation of new in-vitro diagnostics;
- Reporting of diagnostic tests should be transparent and standardised(Regulatory Horizons Council, 2021).
Carlos Francisco Marín Barrios
Regulatory Affairs Department
Should you like to appoint Obelis UK as your UK RP, or if you simply need guidance on your UK documentation, please do not hesitate to contact us.
- The Medicines and Healthcare products Regulatory Agency. (2021a). Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak. Retrieved on 12/07/2021 from https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak#approval-for-ventilators-ppe-and-covid-19-testing-kits
- The Medicines and Healthcare products Regulatory Agency. (2021b). Medical devices given exceptional use authorisations during the COVID-19 pandemic. Retrieved on 12/07/2021 from https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic