In Vitro Diagnostic regulation (IVDR)

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.

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 26^th, 2025
  • Class C products valid until May 26^th, 2026
  • Class B and Class A sterile products valid until May 26^th, 2027

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.