Commissioned by Innovate UK, ISO Life Sciences Ltd was asked to look at the state of readiness of the UK in-vitro diagnostic sector ahead of new EU regulations.
The regulations are due to come into force on 26 May 2022.
Issues, challenges and needs
Innovate UK’s intent is to raise awareness of the issues, challenges and needs of the UK in-vitro diagnostics (IVD) sector and to engage critical stakeholders to help formulate action plans.
The report notes:
In response to the needs placed on the UK IVD sector, government and regulators, has emerged the unprecedented demonstration by all parties to operate in such a way as to get things done.
What has emerged is closer cooperation across business silos, changes to working practices between businesses, accelerated business actions for results.
The report’s key recommendation is:
In relation to IVD regulations transitioning, the UK IVD sector, policy makers and regulators, notified bodies and government agencies need to similarly ‘act together’.
Dr Michael Kipping, Innovate UK’s Innovation Lead, Biomedical Catalyst, said:
The report highlights that throughout the COVID-19 pandemic the in-vitro diagnostic sector has achieved much by acting together.
By taking the same approach the sector can meet the challenge of regulatory change.
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