MHRA Spells Out Post-Brexit Regulation of Medical Devices Under No-deal Scenario
With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions. From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requirements, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) fleshed out guidance from January on the no-deal scenario. The 18-page guidance document was issued on Tuesday and is intended to apply on the UK’s 29 March exit day.