BIVDA’s Head of Regulatory Affairs, Ashleigh Batchen, has had an article accepted in the August 2023 issue of the Journal of Medical Device Regulation.
In the article, ‘The future of in-house test requirements in the EU and the UK’, Ashleigh examines the new IVDR requirements for in-house tests and their timeframes for implementation, including transfer to another legal entity, quality management systems, justification on available equivalent devices, device declarations, and surveillance.
She also explains how the requirements for in-house tests in Great Britain differ from those in the European Union.
To access the article, you must subscribe to the journal or purchase the individual article. Details can be found here.
