IVDR Class D Devices – Latest Updates and Experience

Description: The position paper MDCG 2022-14 outlines a number of proposed solutions to ensure that Notified Bodies have adequate capacity to ensure continued availability of medical devices on the EU market. For IVD devices certified by a Notified Body under IVDD 98/79/EC, the paper introduces the concept of leveraging evidence from previous assessments conducted under the Directives to avoid unnecessary duplication of work. However, the position paper does not describe specific requirements for such leveraged reviews.
This session will discuss the approaches taken by Notified Bodies to perform leveraged reviews of Class D devices previously certified under IVDD Annex II List A, including determination of the validity with regard to IVDR requirements and Common Specifications. Notified Body and Industry perspectives on their experience with leveraged reviews will be covered to allow manufacturers to understand the requirements for leveraged review of their existing Class D products.
Aspects of approval of Class D devices in the absence of EU Reference laboratories and transition to EURL once these are designated will also be discussed.
When there are no published Common Specifications (CS) and where it is also the “first certification for that type of device”, then the NB, when making its conformity assessment decision, is obliged to give due consideration to the opinions expressed in the scientific view of the expert panel.
Since the Expert Panel for IVD was appointed in September 2021, a total of eighteen views have been published. The 18 published views have been able to cover various pathogens for which CSs were and are still not available but of course they represent a limited source of information. This session aims to identify some recurrent recommendations and remarks throughout the published views and provide key takeaways for manufacturers and notified bodies to focus on during the device performance evaluation.