Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
\ \ \ \ \
On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body survey on certifications and applications under the MDR and IVDR with data until February 29th, 2024.
Here are the key take home messages to share:
- The number of MDR applications per month have nearly halved in comparison to the previous survey result (from roughly 4500 applications reported for the period between June and October 2023 to roughly 2500 applications for the period between October 2023 and February 2024).
- Under MDR, in the majority of the cases (62%), it takes less than 2 months from an application lodged to a written agreement signed.
- The time to reach a new certificate under MDR is increasing, 40% of notified bodies now report a time between 13 to 18 months for QMS + Product certificates.
- For IVDR the number of applications per month is roughly 60% lower in comparison to the previous survey result (from roughly 340 applications reported for the period between June and October 2023 to roughly 140 applications for the period between October 2023 and February 2024).
- This translates in significantly less IVDR certificates being issued by the notified bodies versus the previous survey period, a drop in more than 50% (!!), from roughly 200 to roughly 100.
- The time to reach a new certificate under IVDR is increasing, 75% of notified bodies now report a time between 13 to 18 months, 17% even report timelines between 19 and 24 months.
- Only close to 800 certificates have been issued under IVDR, of which 173 Class D devices.
- Only about 1600 IVDR applications have been lodged, of which 370 Class D devices.
What does this mean for you?
Although the European Parliament recently approved another extension on the transitional provisions, don’t sit back and relax. Take into account the time you need to prepare your technical documentation in compliance with MDR/IVDR, organise your team and ensure your quality management system is also in compliance with the requirements of the regulations. Currently notified bodies still have capacity, but it is expected that by 2025 this will not be the case. The time to act is now!
with ease.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
Read more订阅生命科学领域的最新动态
专家观点直达您的收件箱——选择您的兴趣。
绝无垃圾邮件。随时取消订阅。
