Medical device CE marking

Medtech Europe Survey – IVD manufacturer


MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD manufacturers on the state of the IVD market today and how they are expected to transition to the IVD Regulation within ten months from the survey date. The survey, which represents an estimated 90% market revenue coverage, was commissioned by the Competent Authorities for Medical Devices (CAMD) Task Force on Certification Capacity Monitoring.

Many IVDs are not expected to receive certification by the deadline of 26 May 2022 under the IVD Regulation. 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. From the survey data, an estimated best-case scenario where 61% of today’s IVDs will be certified by 26 May 2022 and a worst-case scenario where only 24% will.

The full survey report may be read here.