Draft rare disease therapies regulatory framework
MHRA has released a draft regulatory framework for rare disease therapies, which may include medical devices. This framework is open for public consultation to gather stakeholder input on requirements for rare disease therapeutic products.
🔖 Status: in-development
This reform is part of the MHRA's ongoing programme to modernise and strengthen the the UK medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗