Deadline extensions for the introduction of Regulation (EU) 2017/746 with immediate effect
The pandemic continues to grip the world. The bottlenecks at the health authorities and institutions persist. The introduction of REGULATION (EU) 2017/746 on in-vitro diagnostics, also known as IVDR for short, planned for May 27, 2022, comes at a completely inopportune moment for all those involved.
With Regulation (EU)2022/112 of January 25 , 2022, recently published in the Official Journal of the European Union L 19/6 on January 28, 2022, the European Union wants to counteract the risk that the health institutions will be further burdened and possibly health goods that are currently in times of the pandemic are needed to be artificially tightened.
With this ordinance, which, contrary to the usual administrative deadlines, comes into force immediately due to the pandemic, the transitional periods of the IVDR defined in Article 110 are extended and Articles 112 and 113 are adjusted accordingly . The extension of the deadline affects all risk classes of the IVDR.
We have summarized them for you in a compact diagram:
If you have any questions, TentaConsult Pharma & Med GmbH will be happy to advise you!
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Miss Stamm
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Source: https://www.tentamus-web.com/tentaconsult-de/neue-fristen-fuer-ivd-in-europa/
