This morning, the IVDR postponement was published in the Official Journal of the EU. This means that this is now legally binding, and the postponement will take effect.
This pushes back the full implementation of the EU IVDR based on the risk class of the IVD, primarily due to the ongoing Covid-19 pandemic response which resulted in those involved in the IVD sector needing to address unprecedented challenges. There is a lack of EU Notified Bodies designated under the IVDR, meaning that new products requiring Notified Body review would not be able to meet the initial deadlines set.
The delayed timelines bring implementation to the following dates:
26 May 2024 for certain requirements for devices manufactured in-house (2028 where the institution can demonstrate the unavailability of an equivalent device)
Products placed on the market pursuant to transitional periods under IVDD certificates have also been extended by 1 year to 26 May 2025.
26 May 2022 remains the date of application of this legislation, with class A (non-sterile) devices still requiring compliance by this date.
What do I need to do?
There are some caveats to this proposal, and we recommend you familiarise yourself with the requirements to understand when your products would be expected to comply.
BIVDA encourages members to continue to work towards compliance, including gaining a Notified Body as soon as possible where required.