Transition to the IVD Regulation – MedTech Europe Survey Results for October 2022

This is the second annual MedTech Europe survey of the IVD sector and the state of the transition to the IVD Regulation.

It is indisputable that the amending Regulation (EU) 2022/112 of the IVD Regulation’s transitional provisions adopted in January brought significant relief and restored production and availability of IVDs to patients, laboratories and healthcare systems. It also supported the transition to the IVDR: around 21% of today’s total IVD market are already certified under the IVDR. This represents a three-fold increase relative to July 2021.

At the same time, this survey demonstrates that certification bottlenecks leading up to May 2025 are still possible: 51% of Class D legacy devices belong to manufacturers which still do not have an agreement with a Notified Body and cannot yet be certified under IVDR unless such an agreement is secured; a disproportional number of small and medium enterprises (SMEs) still do not have an agreement with a Notified Body designated under the IVDR, which may result in 54% of SMEs not being able to certify their tests unless agreements are concluded on time.

To support the transition to the IVD Regulation including for legacy and innovative IVDs, attention should be given to further building up the infrastructure of the regulatory system, and making conformity assessment shorter, more efficient and more predictable. This includes (but is not limited to), speeding up designation of Notified Bodies and ensuring a workable EU Reference Laboratory system, as well as tackling inefficiencies at every stage of the certification system.

Finally, great attention is given to innovation: the survey shows a 28% drop in manufacturers who would prioritise the EU for first product launches.