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. The full survey report may be read here.
The survey data shows that at least 22% of IVD tests on the market today will be discontinued for the IVD Regulation. In addition to this, many more 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, MedTech Europe estimates a 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 (see Figure 1). This margin of uncertainty comes from the data showing that Notified Body certificates had not yet been issued for 88% of IVDs 10 months ahead of the IVDR application: this is consistent across all risk classes. IVDs which require one or more Notified Body certificates under the IVD Regulation but do not have their certificate(s) by 27 May 2022, must be removed from the EU market (transitional provisions may apply but are limited in scope).
The survey further shows that 53% of manufacturers report that they are unable to sign with a Notified Body to certify their quality management systems and IVDs. SMEs are disproportionately affected by the lack of Notified Body – 64% of SMEs do not have a contract with even one Notified Body compared with 25% of large manufacturers who do not. There is a ~10-fold increase in the number of tests needing Notified Body certificates under the IVD Regulation as compared to today’s IVD Directive). While Notified Body capacity was cited by respondents as a top concern, it was not the only infrastructure challenge. 74% of manufacturers who responded to the survey reported issues in starting or completing certification.
But still the Commission refuses to take these issues seriously!