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MedTech Europe IVDR Impact Report: The Good, The Bad And The Ugly

 
• By Eliza Slawther

The outcome of a survey by trade association MedTech Europe shows that while more than 90% of companies benefited from the extension of IVDR transition deadlines, significant issues remain that could see many diagnostics disappear from the market.

IVDs
• Source: Shutterstock

In January 2022, the European Commission adopted amendments to the In Vitro Diagnostics Regulation that extended the deadlines for compliance with the new requirements to prevent disruption in the supply of IVDs in the EU.

These changes had a positive effect on industry. In a survey of 110 manufacturers conducted by MedTech Europe between 30 September and 27 October 2022, 91% of respondents said...

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