Team NB Publishes Press Release on Certificates with Conditions
19 March 2025
On 12 March 2025, the TEAM NB issued a press release on certificates for which special conditions, regulations or even restrictions can be invoked in accordance with EU MDR 2017/745 and EU IVDR 2017/746 Annex VII Section 4.8. It states that rare and innovative medical devices, in particular, can be brought to market faster by allowing the notified body to issue certificates to manufacturers with certain conditions and restrictions to enable controlled release in the interest of patient safety.
Such restrictions on certificates by the notified bodies include interim surveillance of all PMCF activities, limitation of the intended use (i.e. additional PMCF data is required for certain patient groups), shorter period of validity of the certificate, obligation to record safety and performance data or restriction of the use of the device to certain medical institutions with sufficient expertise.
The possibility of issuing restricted certificates in the context of PMCF/PMPF studies is already referred to in the MDCG 2024-10 guideline on Clinical Evaluation of Orphan Medical Devices) and MDCG 2022-14 (Transition to the MDR and IVDR: Notified Body Capacity and Availability of Medical Devices and IVDs). TEAM NB refers to a Report by the Coordinating Research and Evidence for Medical Devices (CORE-MD) on conditions for notified bodies certificates (Deliverable 3.3), which shows that the possibility of restricting certificates to make innovative and rare devices available has rarely been used so far, although it is very valuable for manufacturers and patients.
TEAM NB therefore recommends that all notified bodies continue to give greater consideration to the possibility of issuing certificates with conditions. In this way, the availability of medical devices for rare conditions and innovations can be ensured, while at the same time the safety of patients from typical risks of such novel devices remains guaranteed through surveillance measures. This will also allow the collection of data to complement clinical evaluation.
If you have any further questions about certification and clinical evaluation, please do not hesitate to contact our experts.
