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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

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

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

Med-Tech Innovation Expo

NEC, Birmingham
5-6 June, 2024

UK NEQAS Blood Coagulation: Clinical and Laboratory Haemostasis 2024

Sheffield Hallam University
5th - 6th June 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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