UK’s updated medical device and clinical trial laws depart from EU regulatory framework | Allen & Overy LLP

We have just witnessed the UK government’s first steps to deviate from the harmonized laws regulating medicines and medical devices that the UK inherited when it left 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 give their views on possible changes to the regulatory framework for medical devices in the UK. Their goal is to develop a future regime for medical devices that allows:

  • improving patient and public safety;
  • greater transparency in regulatory decision-making and information on medical devices;
  • close alignment with international best practices; and
  • more flexible, responsive and proportionate regulation of medical devices.

Writing in the preface to the consultation paper, Sajid Javid, the Secretary of State for Health and Social Affairs, said “… our departure from the European Union gave us new regulatory freedom and a unique chance to reshape our rules. “. He cites the Fan Challenge as an example of tackling problems by bringing together the best minds in manufacturing, innovation and regulation. He also hopes to build on the “Huge advancements in software and artificial intelligence that have the ability to transform healthcare for the better in the years to come through faster diagnoses, faster treatment and better tools for clinicians. “.

Safety and innovation in medical devices are the two objectives of this review. The MHRA offers “A bold new regulatory framework” through:

  • creating new pathways to support innovations, which the MHRA says will ensure the UK remains an excellent place to launch new medical devices and avoid repeat reviews, giving patients early access to new treatments while maintaining strong safety standards and further capitalizing on our global reputation for R&D and NHS;
  • a unique, innovative and ambitious framework to regulate software and artificial intelligence as medical devices. The MHRA’s view is that it would be a leading regulatory model that would tackle many challenges ahead of its international peers, ensuring the UK attracts a world-class life science industry. and innovators without compromising safety;
  • reforming in vitro diagnostic (IVD) regulations to update the classification and include an in-depth review of risks to patients, recognizing the central role diagnostic devices have played in the UK’s response to the Covid pandemic -19;
  • become a pioneer of sustainable development through the safe reuse and remanufacturing of medical devices, providing a substantial opportunity to reduce single-use medical devices, help achieve the UK government’s Net Zero goal, support the Greener NHS initiative and improve supply chain resilience.

The consultation papers offer a very detailed set of possible proposals that those consulted can comment on in an online survey, ranging from a reformed medical device classification system to stricter requirements for insurance coverage in the event of claims. in product liability.

The consultation ends on November 25, 2021.

In the same week, Brexit Minister Lord Frost told the House of Lords, when considering proposed legal changes after Brexit, announced that “We will use the provisions of the Medicines and Medical Devices Act 2021 to revise our clinical trial frameworks, on the basis of outdated EU legislation, giving a boost to the UK’s world-class R&D sector and enabling patients to access life-saving new medicines faster.”. Lord Frost also said that the regulation of genetically modified organisms (GMOs), which currently replicates the EU’s approach, would be reviewed because “It’s too restrictive and is not based on solid science”. It may also have a favorable effect on the development, testing and use of drugs in the UK which incorporate a GMO component in their manufacture.

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