According to the data from the October 2022 survey, more than 1,000 MDD/AIMDD certificates expired in 2022, and more than 4,000 MDD/AIMDD certificates are expiring this year. Moreover, the MDD/AIMDD certificates expiring in 2024 are more than 17,000. It is essential to know the situation of MDR applications and certificates issued to ensure sufficient medical device supply while the MDR guarantees quality. Therefore, a survey on certifications and applications of MDR and IVDR was sent to 39 notified bodies (NB) designated under MDR and/or IVDR in April 2023 and closed in May 2023 with a 100% response rate.

In this survey, 29 NBs are designated under the MDR of 39 NBs. 9 NBs are designated under both the MDR and IVDR, while one NB is designated under the IVDR. The first section of the survey focuses on the numbers of MDR and IVDR applications, e.g., the number of applications filed and certificates issued, the applications and certificates by annex, and by type (QMS vs. Product). In addition, the average time between the application lodged and the written agreement signed, as well as the time to reach a new certificate, are also investigated. In addition, the reasons for refusal and time to reach a new certificate are also presented in the survey results.

If you are interested in the survey results, please consult the link below.

Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR)