The future of Medical Device Regulation in the UK: a post-Brexit outlook

Since its departure from the European Union, the regulation of Medical Devices has been governed by requirements derived from the European Medical Devices Directive. All medical devices imported or placed on the market within the European Union will soon have to comply with the updated Medical Devices Regulations, something that medical devices in Great Britain will not need to comply with.

In the backdrop of this misalignment in regulatory requirements between GB and EU (+ Northern Ireland), a new report published today (August 19, 2021) by the Regulatory Horizons Council sets out how the UK may take advantage of its ability to strengthen Medical Devices regulation in the UK.

The report identifies a number of key areas where the UK may focus its efforts including in the regulation of implantable defibrillators and pacemakers with the intention of putting patients at the core of decision-making processes.

The intention conveyed within the report signals how the UK may more quickly respond to advances in Medical Device technologies with a focus to work with like-minded regulators in shaping international regulation.

Due to the size and complexity of the European Union, the passing of new Directives and Regulations is often seen as a cumbersome process that takes many years to implement. It appears that the focus of the UK regulatory authorities may be to use its size and agility to become an international authoritative voice for future development in the regulation, not only Medical Devices but also in other areas of regulation.

To read the report in full please click here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1012043/rhc-medical-report.pdf

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