MedTech Europe ran its latest survey to gather data from IVD manufacturers on the state of the IVDR regulatory infrastructure. The survey represents an estimated 75% market revenue coverage, and the full report and its annex with visuals of the results may be read here.
It is indisputable that the amending Regulation (EU) 2022/112, which extended the IVD Regulation’s transitional provisions, brought significant relief and protected patients, laboratories and healthcare systems from immediate shortages of needed IVD medical tests. Around 21% of today’s total IVD market is already certified under the IVDR. This represents a three-fold increase compared to July 2021.
At the same time, there are significant challenges which must be addressed to ensure a successful transition by the May 2025, May 2026, and May 2027 regulatory deadlines:
- Access to a Notified Body remains a hurdle, especially for small and medium-sized enterprises, 53% of which do not yet have a contract with a Notified Body. Access to an IVDR-designated Notified Body is a first critical step for transitioning to the Regulation and is especially critical issue for 51% of Class D legacy devices, which are still not covered by a Notified Body agreement.
- Conformity assessment timelines vary excessively– including the times taken to pass Notified Body’s pre-review phase, review phase and issuance of the certificate.
- Ongoing regulatory uncertainty is harming innovation: the survey shows a 28% drop in manufacturers who would prioritize the EU for first product launches compared to one year ago.
“Medical tests play a crucial role in modern healthcare, a truth that the COVID-19 pandemic made painfully clear. In vitro diagnostic (IVD) medical tests are routinely used across Europe’s hospitals, laboratories, and households to diagnose and screen for a huge range of medical conditions affecting patients. To ensure that everyone in Europe continues to have seamless access to a sufficient variety of IVD medical tests, the EU regulatory infrastructure needed to lawfully bring such tests to market must run smoothly.” Oliver Bisazza, CEO of MedTech Europe.