FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Separate UK Regulations Are Bad for Business, Stakeholders Warn

Sept. 27, 2017
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Creating two distinctive regulatory frameworks would disrupt innovation and growth for the EU and the UK’s medtech industry and hinder access to needed medical devices, said medtech stakeholders concerned about the effect of the impending exit of the UK from the European Union.

A transitional period to implement secondary legislation for devices and in vitro diagnostics is needed to maintain parity of regulation with the EU, stakeholders said in a letter to Michel Barnier, the EU’s chief negotiator, and UK Member of Parliament David Davis, the UK’s secretary of state for the Department for Exiting the European Union.

Signed by leaders of MedTech Europe, the Association of British Healthcare Industries and the British In Vitro Diagnostics Association, the Sept. 12 letter stressed the need for sector-specific measures to be implemented during the ongoing Brexit negotiations.

The letter urges the leaders to adopt the EU’s new regulations covering medical devices and IVDs to encourage global harmonization and to keep EU-wide networks strong.

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