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| 1 minute read

Much-anticipated EU regulations on diagnostic medical devices come into effect

Well, it's finally here. Yesterday marked the Date of Application of the European Union's new In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR), a revolutionary piece of legislation which (for better or worse) will have a tremendous impact on the MedTech industry in Europe.

There are some serious challenges: Notified Body capacity is still far below where it needs to be, and the guidance which is intended to help industry interpret the new rules under the IVDR has been slow to arrive and often unhelpful. It is difficult to predict exactly how the next few months and years will play out for the IVDR, but one thing is certain: there is change afoot.

We’ve written a number of articles in the last few weeks to explain the challenges – you can catch up on the “Spotlight on IVDR” series here:

Diagnostic medical devices are key for lifesaving and innovative healthcare solutions. Today we are marking a big step forward for the patients and the diagnostics industry in the EU. The COVID-19 pandemic has underlined the importance of accurate and safe diagnostics, and having stronger rules in place is a key element in ensuring this is the case for EU patients.


health tech, life sciences, life sciences regulatory, technology

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