MedTech Europe Survey Report – Analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies

During the month of July 2021, MedTech Europe members participated to a survey commissioned by the Competent Authorities for Medical Devices (CAMD) Task Force on Certification Capacity Monitoring assessing the availability of IVDs after the entry into full application of the In vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. The companies that participated to this exercise represent an estimated 90% market revenue coverage.

The responses by the companies that participated to the survey lead to the following conclusions:

1. At least 22% of IVD tests on the market today will be discontinued for the IVD Regulation. In addition to this, many more IVDs will be lost if no urgent solutions are found to address the existing transition issues to the IVD Regulation. In July, certificates had not yet been issued for 88% of devices.
2. The added loss is avoidable and preventable.
3. The highest proportionate loss of IVDs will come from small and medium sized manufacturers, many of whom make niche products in smaller volumes and who may be more prone to run out of business.
4. The lack of a sufficient number of operational Notified Bodies is a significant issue – 53% of manufacturers do not have a Notified Body.