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21 July 2017

posted Jul 21, 2017, 12:05 AM by Beck Lockwood   [ updated Jul 21, 2017, 2:12 AM ]

A changing regulatory landscape for IVDs

Significant changes to European regulations for in vitro diagnostics (IVDs) have now been published and are due to be introduced over the next five years. 

The transition period allows manufacturers time to update technical documentation and processes to meet the new requirements. However, they will now find themselves subject to greater scrutiny of documentation, clinical evaluation, post-market clinical performance reviews, and traceability of devices through the supply chain.  

The implications of these changes were explored at a workshop, organised by the MHRA and MRC, which was held at the Academy of Medical Sciences, London, in May. Dr Michael Messenger, Deputy Director NIHR DEC Leeds, was invited to present a series of case studies, demonstrating methodological approaches to complying with some of the regulatory requirements.

“The DECs were set up to accelerate adoption of new IVDs into health and care systems and we welcome the increased clarity and rigour that these new regulations will bring,” says Dr Messenger.

“We will be monitoring new developments closely and we’re looking forward to continuing to work with our partners within these regulations to deliver new diagnostic tests which are both accurate and cost effective – and can deliver real benefits to patients.”

The NIHR DEC Leeds is keen to support the UK diagnostic industry through this regulatory transition period, by offering help with regulatory studies of scientific validity, analytical performance and clinical performance.  For further information please contact us.

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