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Updated UK Laws on medical devices and clinical trials to diverge from EU regulatory framework

We have just witnessed the first moves by the United Kingdom government to diverge from the harmonised laws regulating medicines and medical devices that the UK inherited on leaving the European Union at the end of January 2020.

The MHRA has just launched a consultation inviting members of the public, including developers, manufacturers, and suppliers, to provide their views on possible changes to the regulatory framework for medical devices in the UK. Their aim is to develop a future regime for medical devices which enables;

  • improved patient and public safety;
  • greater transparency of regulatory decision making and medical device information;
  • close alignment with international best practice; and 
  • more flexible, responsive and proportionate regulation of medical devices.

Writing in the foreward to the consultation document, Sajid Javid, the Secretary of State for Health and Social Care says “… our departure from the European Union has provided us with a new found regulatory freedom and a unique chance to reshape our rules.”.  He cites the ventilator challenge as an example of confronting problems by bringing together the best minds in manufacturing, innovation and regulation. He also hopes to build on the “enormous leaps in software and artificial intelligence which have the capacity to transform healthcare for the better in the years ahead through quicker diagnostics, faster treatment and better tools for clinicians.”.

Safety and innovation in medical devices are the twin targets of this review. The MHRA proposes “a bold new regulatory framework” through: 

  • creating new access pathways to support innovations, which the MHRA says will ensure the UK remains an excellent place to launch new medical devices and avoid repeat assessments, granting early patient access to novel treatments whilst maintaining robust safety standards and capitalising further on our global reputation for R&D and the NHS;
  • a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices. The MHRA’s view is that this would be a leading regulatory model that will address many challenges ahead of international peers, ensuring that the UK attracts a world-class life sciences industry and innovators without compromising on safety;
  • reforming in vitro diagnostics (IVD) regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in the UK’s response to the Covid-19 pandemic;
  • becoming a sustainability pioneer through the safe re-use and re-manufacture of medical devices, offering a substantial opportunity to reduce single-use medical devices, help reach the UK Government’s Net Zero target, support the Greener NHS Initiative, and improve supply chain resilience.

The consultation documents offers a very detailed set of possible proposals for consultees to comment on in an online survey, from a reformed system of classification for medical devices to stricter requirements for insurance coverage in the event of product liability claims.

The consultation closes on 25 November 2021.

Within the same week, the Brexit minister, Lord Frost told the House of Lords, in reviewing proposed post-Brexit legal changes, announced that “We will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and getting patients access to new lifesaving medicines more quickly.”. Lord Frost also said that the regulation of genetically modified organisms (GMOs), which currently replicates the EU approach, would be reviewed because “it is too restrictive and not based on sound science”. This may also have an enabling effect on the development, testing and use of medicines in the UK that incorporate a GMO component in their manufacture.