New proposals to strengthen medical devices regulation

A new report sets out how the UK could strengthen the regulation of medical devices, learning lessons from the response to the coronavirus pandemic.

The Regulatory Horizons Council, who published the report, is an independent expert committee which identifies the regulation needed to foster technological innovation and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction.

Their 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 identifies the UK’s departure from the European Union as an opportunity to build a UK-specific regulatory system that puts patients at the heart of decision-making processes, highlighting 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.

The RHC also calls for lessons to be learnt from the UK’s pandemic response, including addressing delays in medical device approval so that equipment can be authorised effectively and at speed. It also recommends that pandemic preparedness should include fast-track evaluation of new in vitro diagnostics and that reporting of diagnostic tests be transparent and standardised.

Life Sciences Minister Nadhim Zahawi said: “Our life sciences industry is at forefront of global, modern regulation, as demonstrated by the speed and flexibility of the UK’s development and rollout of Covid vaccines. Today’s report supports our ambition to capitalise on the UK’s departure from the European Union and put in place streamlined regulation that will ensure we can bring to market safe and effective medical devices quickly, benefitting patients across the country.”