How Stormy UK Politics Could Intrude On Medtech Regulatory Readiness
The current turmoil at the heart of the UK government is the last thing the medtech industry needs right now as it awaits publication of the new, post-Brexit UK medtech regulations.
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26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.
While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.