In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for Class D devices is fast approaching. The recent survey results published by the EU Commission concerning the period ending in June 2023, show that a total of 231 applications have been received and a total of 62 certificates have been issued for Class D devices. These statistics are quite alarming and have pushed Team Notified body to publish a call to action for manufacturers of Class D IVD devices. The concern is stemming from the fact that the initial conformity assessment process for high-risk devices, such as Class D devices, covered by a product Annex Certificate could take between 13 and 18 months. With the deadline for Class D devices approaching rapidly, Team Notified body recommends that manufacturers contact a notified body of their choice now and submit their applications as soon as possible. They strongly recommend that manufacturers submit their applications by no later than end of 2023, in this way, if the conformity assessment will take 18 months, they will have enough time to complete this process and obtain their certificate before the deadline. The call to action also stresses that applications submitted after the recommended date will be at risk of having their certificates issued after the deadline, leading to possible problems in the supply chain of IVD’s.
Notified Bodies that have jointly committed to this call to action give the following recommendations to device manufacturers:
- Contact a notified body of your choice that has been designated to carry out the conformity assessment for the types of devices you have in your portfolio without any further delay. You can find the scope of notified bodies on the NANDO website using the following link
- Prepare the application making use of the forms, tools, and guidance available and submit them to the notified body on time, including best practice guidance documents representing the views of notified bodies. Best practice documents issued by Team NB can be accessed using the following link
The Urgent Call to Action can be Accessed using the following link
