The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (hereafter: IVDR) entered into force on May 26th, 2017. The IVDR replaces the In Vitro Diagnostic Medical Devices Directive 98/79/EC (hereafter: IVDD). In order to ensure a smooth transition a transitional period of five years has been implemented. This means that until May 26th, 2022 in vitro medical devices may also comply with the requirements of the IVDD.
Conformity assessment procedures
Manufacturers of in vitro diagnostic medical devices of class A non-sterile are responsible for complying with the legal requirements. As the IVDR is already in force, it is highly recommendable to comply with the requirements stated in the IVDR, as the IVDD will be repealed after the transitional period.
For all in vitro diagnostic medical devices with a risk class higher than class A non-sterile, an assessment by a Notified Body is required. Even though the IVDR is already in force, the Notified Bodies are not yet accredited to perform assessments on the basis of the IVDR. This means that an assessment by a Notified Body of your in vitro diagnostic medical device shall be based on the IVDD. As we are progressing to the end of the transitional period, more Notified Bodies will be accredited in accordance with the IVDR.