In the IVDR, Chapter IV (Articles 31 to 46) and Annex VII describe in great detail the minimum requirements to be fulfilled by a Notified Body applying to be designated by a Competent Authority IVDR assessments. These requirements have increased drastically compared to the IVDD. Some of these criteria are around their organizational structure, legal status, and finances. There are several specific requirements to be met related to competency i.e., having sufficient and qualified resources with the necessary level of knowledge and experience to evaluate the IVD medical devices subject to review. These are the requirements that have been consistently difficult to meet. Other criteria specify the details for quality management systems, sub-contracting, external experts/SMEs, and so on. Henceforth, notified bodies will be subject to a peer review and a complete re-assessment to determine whether they still satisfy the requirements every three years after notification, and again every fourth year thereafter. Clearly, the scrutiny of the notified bodies has increased multi-fold.
Annex VII stresses that notified bodies must maintain strict confidentiality and impartiality during assessments. Overall, the requirements have increased and as a result, fewer notified bodies have applied for IVDR designation.