In Vitro Diagnostics Regulation Is Going to Replace IVDD in Europe

July 9, 2020

With no anticipated COVID-19 extension for IVDR as with MDR, the regulation goes into effect in mid-2022

On May 26, 2022, the In Vitro Diagnostics Directive (IVDD) will cease to govern manufacturers seeking clearance to market in the European Union, and instead the In Vitro Diagnostics Regulation (IVDR) will be enacted. Manufacturers will have a grace period of two years to get their Declarations of Conformity in place to remain on the market.

Important implications for in vitro diagnostic (IVD) developers from the regulation are listed below:

  • Under IVDD, approximately 20% of products required Notified Body involvement. Under IVDR, that number is expected to grow to over 90%. To date, only two Notified Bodies are certified as able to assist with reviewing IVDR applications, and the lines for applications are already beginning to form. If you know you will need to apply for IVDR authorization, begin the conversations with your Notified Body today.
  • After May 26, 2022, products brought to market under IVDD will effectively be held under design freeze until they are recertified under IVDR, meaning no amendments to their MDD Declaration of Conformity will be approved. Notified Bodies are warning that until more Notified Bodies are certified, IVDR applications submitted in late 2021 will not be able to be reviewed by the May 26, 2022, deadline. Notified Bodies urge early submission.
  • The Intended Purpose has been reworked under IVDR and is now much more explicit with the need to identify both the target medical condition and population as well as supporting scientific evidence of validity. The scope of the Intended Purpose will govern many other elements of the required documentation and is worthy of careful consideration under IVDR.
  • The Notified Bodies, and eventually the Competent Authorities, will be inspecting not only the submitted documentation against the claims and Intended Purpose but all other marketing claims present or potentially presentable by the manufacturer, including websites and social media presence. Ensure that all marketing materials align with the Intended Purpose and associated claims.

For more information, the full regulation is available here.

How Exponent Can Help

Exponent has a team of professionals with IVD industrial experience and IVDR training ready to assist with compiling the application and guiding companies towards submission. The exercises most commonly performed in anticipation of IVDR compliance are gap analyses, portfolio examination, risk management documentation creation, formal literature searches in support of scientific validity claims, and clinical validation and postmarket surveillance/performance evaluation.