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In Vitro Diagnostic regulation (IVDR)

The in vitro Diagnostics Regulation (IVDR) (EU) (2017/746) is the new EU legislation applicable to in vitro diagnostic medical devices placed on the European market. This new regulation comes with increased safety and performance requirements for IVD manufacturers and a stronger role for conformity assessment bodies to ensure the highest level of public health protection.

New risk-based product classification

Under the new IVDR regulation, all IVD products must be classified according to a new product classification based on both patient and public health risk.

Transition timelines

IVDR applies to all In Vitro Diagnostic Medical Devices placed on the European market, however a progressive roll-out is planned to ensure a smooth transition to the new requirements:

  • IVDR applies from May 26, 2022, for all Class A non-sterile products and all new IVD medical devices launched in the European market.
  • Other products already placed on the market under the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC are still valid according to the following timeframe:
    • Class D products valid until May 26th, 2025
    • Class C products valid until May 26th, 2026
    • Class B and Class A sterile products valid until May 26th, 2027

IVDR regulation transition timeline

Our commitment

At PerkinElmer, we are committed to delivering the highest safety and performance standards for our products. With over 30 years of experience in developing IVD medical devices, we have developed robust manufacturing processes which ensure a full compliance with the new IVDR regulation.

If you own a PerkinElmer IVD product, no action is needed from your end during the IVDR transition, we take care of fulfilling all new conformity requirements.

Question Mark Block

Frequently Asked Questions

As any new change comes with questions, we have prepared a FAQ document to help you find the information you need. However, don’t hesitate to reach out to your local sales representative should you have any further additional question.

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