Amid Reforms, Brexit, UK IVD Firms Battle Funding And Adoption Issues

The EU In Vitro Diagnostics Regulation and Brexit loom large for UK IVD companies, but manufacturers serving the $1.6bn UK IVD market have many other competing concerns. It’s the most challenging period in more than 15 years, according to the British In Vitro Diagnostics Association Chief Executive Doris-Ann Williams.

Brexit is understandably the talk of the town, yet there's still nothing to say of any gravity about it, nine months on from the UK's vote to leave the EU. So says Doris-Ann Williams MBE, chief executive of the British In Vitro Diagnostics Association (BIVDA), speaking to MedTech Insight early in the month that UK Prime Minister Theresa May finally invoked Article 50 of the Treaty of Lisbon, thereby beginning the divorce talks between the UK and the EU and its remaining 27 member states.

For all the airy exhortations that the UK must now must "come together" in this most dubious of ventures, it has been a divisive and polarizing episode; the leave process will only make an already hard job harder still. And as to the oncoming EU IVD Regulation (IVDR), "all British manufacturers will need to comply with EU regulations to sell anywhere else in the world," said Williams, referring back to BIVDA's 2016 survey of members

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