The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies in order to allow medical devices and IVDs to be certified in accordance with the MDR and the IVDR within the transition periods. To propose solutions for the challenges, the MDCG lists some actions to enhance capacity of notified bodies, access to notified bodies and manufacturers’ preparedness in this document, including 4 topics.

In this article, only representative actions are pointed out. Details can be found in the attachment.

  1. ● Increase notified bodies’ capacities
    1. - Actions to avoid unnecessary duplication of work and eliminate administrative workload
      - Ensuring proper conformity assessments timely and efficient by means of training for the personnel
  2. Access to notified bodies
    1. - Reminding notified bodies to make their standard fees publicly available
      - Developing schemes to allocate capacity for SME manufacturers and first-time applicants
  3. Increase preparedness of manufacturers
    1. - Reminding manufacturers to ensure timely compliance with the MDR and the IVDR
      - Organizing structured dialogues during the process to enhance the efficiency
  4. Other actions facilitating transition to MDR/IVDR and/or avoiding shortage of device
    1. - Additional guidance to notified bodies and manufacturers to assist with the practical application
      - Urging medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance



MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs