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Future regulatory changes for medical devices and IVDs: the pathology edit

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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Upcoming Events

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24 May, 2024

Med-Tech Innovation Expo

NEC, Birmingham
5-6 June, 2024

UK NEQAS Blood Coagulation: Clinical and Laboratory Haemostasis 2024

Sheffield Hallam University
5-6 June, 2024

LabMedUK24

DoubleTree by Hilton Brighton Metropole
10-12 June, 2024

Infection Diagnostics Symposium 2024

IET Austin Court, Birmingham
26-27 June, 2024

SHOT Symposium 2024

Mercure Manchester Piccadilly Hotel
9 July, 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

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