IVDR Transition

The new In-Vitro Diagnostic Device Regulation (IVDR) entered into force on the 25th May 2017 (with a five year transition period) and replaces the In-Vitro Diagnostic Device Directive (IVDD). 
The new IVDR introduces challenging requirements upon manufacturers who must comply by the May 2022 deadline. Manufacturers will have to update all IVD technical documentation and it is worth noting that many devices will be moved to higher classifications and require Notified Body certification.
With over 25 years of expertise in this area we can work with you to ensure your IVD devices remain compliant and able to be sold across European markets.

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