Introduction
The MDCG acknowledges the significant and urgent challenges in ensuring sufficient capacity of notified bodies to certify medical devices and IVDs in compliance with the MDR and the IVDR during the transition periods. To address these challenges, the MDCG has outlined several actions to improve the capacity of notified bodies, access to these bodies, and manufacturers' preparedness in this document, highlighted through four main topics.
Key Actions
Increase Notified Bodies’ Capacities
- Action aimed at avoiding unnecessary duplication of work and reducing administrative workload.
- Ensuring timely and efficient conformity assessments through training for personnel.
Access to Notified Bodies
- Notified bodies are reminded to make their standard fees publicly available.
- Development of schemes to allocate capacity for SME manufacturers and first-time applicants.
Increase Preparedness of Manufacturers
- Manufacturers are reminded to ensure timely compliance with the MDR and IVDR.
- Organized structured dialogues during the process to enhance efficiency.
Other Actions to Facilitate Transition to MDR/IVDR And Avoid Device Shortages
- Additional guidance provided to notified bodies and manufacturers to assist with practical application.
- Urging medicine authorities to efficiently process consultations by notified bodies regarding medical devices that incorporate an ancillary medicinal substance.
Reference
MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs.