If you follow our posts, you will be well aware that we keep saying, “Don’t take your foot off the gas”. It now appears that this statement is more important than ever.
The Commission has issued its most recent survey on the MDR and IVDR transition process, and the following slide makes sobering reading.
Notified Bodies Survey on certifications and applications (MDR/IVDR) Survey results with data status 31 March 2023: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
Manufacturers are still finding the IVD learning curve hard, and 60% of applications are only 25% complete. This means the process takes more time and more resources to complete.
We keep encouraging manufacturers to factor this into their transition plans to avoid disappointment. It appears DEKRA has gone one step further, and in a recent newsletter, they have introduced IVDR application deadlines as follows.
The deadlines for submitting IVDR files in order to meet the transition timelines are:
- class D: 1 December 2023
- class C: 1 December 2024
- class B and A-sterile: 1 December 2025
Notified bodies have been encouraging manufacturers to apply as soon as possible, especially as many have the capacity to start work now; however, IVD NBs reported at RAPS that they have seen up to a 50% reduction in applications following the extension to the MDR.
It looks like manufacturers think there will be an extension to the IVDR transition; however, the Commission and Competent Authorities at the same conference indicated that it is now a matter of credibility, and they do not intend to extend further. Manufacturers could be playing a dangerous game of chicken with their portfolios.
We highly recommend that you seek notified body approval for at least one product so that you can learn from the experience and reduce the timeline for the application process with expertise.
If you need any advice or help in starting the application process, please get in touch with our IVD team at:ivd@qservegroup.com.
Note: From 11-13th October, Qserve presents the 5th Qserve MedTech Conference in Amsterdam. During the program, there will be an IVD stream where one presentation will cover this specific topic. We are updating the conference program, providing you with more detail. Visit our website to stay informed and learn from the experts during the conference.