UK| New report offers for strengthening medical devices regulation

The Regulatory Horizons Council of United Kingdom has published a new report on August 19, 2021 proposing guidelines on how UK could strengthen the regulation of medical devices, learning lessons from the response to the coronavirus (COVID-19) pandemic while boosting the UK’s world-class life sciences sector.


Key highlights of the report are:

  • Provides opportunities for the UK to create UK-specific regulation, post BREXIT.
  • Based on the government’s new Life Sciences Vision, which outlined ambitions for the sector over the next decade, putting it at the heart of plans to build back better from the pandemic
  • The new proposals set out how medical devices such as pacemakers or implantable defibrillators should be regulated to ensure we can tackle healthcare challenges effectively, now and in the future.
  • The report recognizes the need to build a UK-specific regulatory system that puts patients at the heart of decision-making processes – for example by increasing patient representation on expert groups for advice on medical research and devices, and by providing evaluations of medical devices that are easily understandable.
  • It highlights the opportunities now available to the UK, not only to respond more quickly to new advances in technology, but to work with like-minded countries in shaping international regulation.


*Tanvi Singh, Editorial Assistant has reported this brief.

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