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BIVDA-chaired Pathology Alliance Regulatory Webinar

By May 1, 2024No Comments

On 23 April, BIVDA organised and hosted a pathology alliance regulatory webinar for members of the Pathology Alliance. The event was also supported by MHRA and ABHI.

The 90-minute webinar was chaired by BIVDA’s Helen Dent. It was attended by over 200 laboratory and healthcare professionals seeking to understand the changes and challenges related to medical device and IVD regulations.

Joseph Burt, Head of Diagnostics at the MHRA, provided an overview of the future regulations impacting the diagnostics sector. The updates to the future regulations include changes to the scope of in vitro diagnostics, changes to IVD classification system and their essential requirements. This is done with an aim to align with international regulators.

Steve Lee, Director of Diagnostics and Digital Regulation at ABHI, compared the details of the IVD classification system in the EU and the GB. Steve also covered the timelines for placing CE marked IVD devices on the GB market, the European Commission’s proposal to extend the EU IVDR transition timelines and briefed on health institution exemptions.

Finally, Prof. Mike Messenger, BIVDA’s Head of Regulatory Strategy, explained the concept of health institution exemptions in detail and how this would impact the pathology services in the GB. BIVDA ensure that the MHRA recognise the important contribution that in-house testing makes to laboratory medicine and patient care. Ensuring that the UK patients will continue to have access to safe and effective medical tests, including those manufactured in house is a key priority.

BIVDA look forward to working with the pathology community to ensure a smooth transition to the new regulations.

Ben Kemp