The Government is committed to the safe and effective regulation of medical devices in the United Kingdom; ensuring patients and the public have fast access to new, innovative devices.
The future regulatory system for medical devices is subject to negotiation. The White Paper proposal sets out a proposed UK-European Union free trade area for goods, to ensure continued frictionless access at the border to each other’s markets, underpinned by an upfront commitment to a common rulebook on goods and a Facilitated Customs Arrangement to avoid customs checks and controls at our borders.
Furthermore, UK and EU negotiating teams have already agreed a time-limited implementation period that will maintain access to each other’s markets on current terms - providing certainty for businesses across the EU and UK and time to prepare for the future.
On 22 August the Government also set out its plans for medical devices regulation in the unlikely event of no deal, through a technical notice. This announced that the UK will recognise medical devices approved for the EU market and CE-marked, and will also comply with all key elements of the Medical Devices Regulation and the in vitro diagnostic Regulations, which will apply in the EU from May 2020 and 2022 respectively.