The Dutch Healthcare Inspectorate (IGJ) recently published the results of a survey it conducted among manufacturers of in vitro diagnostic medical devices (IVDs). With this survey, the IGJ wanted to gain insight into the transition to the new European regulation for in vitro diagnostic medical devices (IVDR) and its compliance among IVD manufacturers.
The IVDR has been in force since the 26th of May 2022. The IVDs that were placed on the market after the IVDR came into force and IVDs falling into the lowest risk class (A) must comply with the new regulations since then. IVDs (not belonging to the lowest risk class) placed on the market before the 26th of May 2022 are subject to transitional rules (legacy IVDs). The IVDR will gradually apply to these devices.
The survey found that at least 30% of the surveyed manufacturers do not comply with key requirements of the IVDR which are already applicable. The IGJ estimates that the actual proportion is higher, as the results of the survey concern only those manufacturers who themselves have indicated non-compliance with the IVDR. The results of the survey have prompted the IGJ to conduct random inspection visits to manufacturers based in the Netherlands. In doing so, the IGJ will check whether manufacturers comply with IVDR requirements for post-market surveillance (PMS) and vigilance. Related to this, a ‘post-market surveillance (PMS)’ assessment framework has also been drafted (in Dutch).
Not sure whether you meet the (new) IVDR requirements? Consult the assessment framework or contact Dimitri van Hoewijk or Marieke Bettelheim. We are happy to be of service.