With a little more than a month to go till the date of application of the MDR, the industry is understandably concerned about the readiness of the system. However, another deadline is looming, as the five-year transition period of the IVDR is almost over, with the date of application of the IVDR only one year away. The IVDR introduces the requirement for all products falling into a higher risk class than A to be certified by a notified body. This applies particularly to a large number of products that manufacturers have been able to place on the market without the involvement of a notified body. Only a small portion of IVDs will benefit from the grace period the IVDR grants viz. the few that were already required to be certified by a notified body under the Directive.
The MDCG has only published two documents on the IVDR implementation so far, the latest discussing the transitional provisions for certification of class D in vitro diagnostic medical devices.
In addition to applying to a notified body, some class D applications must be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). The latest MDCG document outlines how the provisions of the IVDR can be applied during the transition period, which means before the date of application on 26 May 2022. It states that in the absence of the required expert panel and/or EURL:
- notified bodies may not issue a certificate before the expert panel is operational and, for the devices that require consultation of the panel, before the panel has provided its views;
- if no EU reference laboratory (EURL) is designated for the device in question, the expert panel should provide its views within 60 days;
- the notified body and manufacturer should follow the EURL-related provisions on sample or batch testing from the time that the EURL becomes operational;
- the notified body should follow the EURL-related provisions for performance verification at the time of the re-certification.