The IVDR Clock is Ticking... But Should There be Alarm?

Description: Coming up to seven years from publication IVD Regulation (IVDR, (EU) 2017/746), the reality of the regulatory transformation for IVD CE marking will come into sharper focus. A new proposal for extending the IVDR transition dates has been issued (COM/2024/43).

An MDCG guidance was published (MDCG 2022-14) to support the successful implementation of the IVDR and capacity of Notified Bodies (NBs). Over a year on, MedTech Europe (MTE) submitted an open letter to the European Commission calling for further improvements of the CE marking system to support efficiency and drive innovation. This educational panel session of NBs and representatives from industry, including MTE, will firstly address what regulatory measures are at their disposal to drive more efficient conformity assessments to maintain access of safe IVDs to patients and support innovation.

The clock strikes on the first transition deadline for Class D IVDs, and devices certified to the IVD Directive (Annex II and self-tests). With this deadline in mind and the proposed transition amendment, and the expected designation of EU Reference Laboratories (EURLs), the panel will discuss how the certification of Class D devices will be transitioned under EURL scrutiny, and how this may vary due to EURL scopes. In addition, using recent surveys of certifications and NB feedback, this session will discuss the volume of Class D device applications and NB certificates under IVDD, that are yet to be certified to the IVDR.

The second transition date a year after will be coming into focus for many industry stakeholders. As Class C devices represent more than 25% of devices on the market (according to MTE 2022 figures), and these devices will not have been under NB scrutiny before, this will likely test the new regulatory framework, and all those involved, to their limits. What is the current progress of Class C device certifications against market figures, and should there be alarm?