EU IVDR Conformity Assessment Options for In Vitro Diagnostic Medical Devices

Beginning on May 26, 2022, new in vitro diagnostic (IVD) medical devices intended to be marketed in the European Union (EU) must comply with the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR1). From this same date, IVDs bearing a valid CE Marking may continue to be marketed in compliance with the Directive 98/79/EC (IVDD) until the expiration date of their certificate. Starting on May 27, 2025, all IVDs marketed in the EU must be compliant to IVDR.

IVD manufacturers must select an appropriate route to conformity assessment (Annexes IX through XI). Device classification partially determines the route. Classification of IVDs in the EU is regulated by Annex VIII of the IVDR and results in four risk-based classes (A, B, C, and D), taking into account the intended purpose of the devices and their inherent risks. Depending on the IVD class, the manufacturer may choose the appropriate conformity assessment route to demonstrate compliance with the Regulation.

In this white paper, you will learn the conformity assessment route options for IVDs under the IVDR, and considerations for selecting the appropriate route for your product.