Starting a new series of articles on the changing state of regulation for medical devices and in vitro diagnostic equipment, Ashleigh Batchen, Head of Regulatory Affairs at BIVDA (the British In Vitro Diagnostics Association) writes for Pathology in Practice looking at the current situation and forthcoming changes as a result of Brexit.
The requirements on products supplied into the UK are in flux as a result of the UK leaving the EU. Legislation is having to be rewritten, and the UK Government is taking this opportunity to make requirements that were previously EU requirements more UK-appropriate.
One of the areas that is getting a major overhaul is MedTech (medical devices and in vitro diagnostic medical devices); products that you likely use as part of your day-to-day activities. Are you up to speed on how these changes might impact you as a user?
Regulatory history
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