The date of application for the IVDR is the 26 May 2022 – just one month away! There has been a huge amount of work to get us to this point, and I hope all our members are working towards IVDR compliance as quickly as possible.
Where your products are benefitting from the amended transition periods published in January 2022, you still have a number of obligations that need to be met from 26 May 2022.
As a recap, the transition periods are now:
Products placed on the market pursuant to transitional periods under IVDD EU Notified Body certificates have also been extended by 1 year to 26 May 2025. Class A (non-sterile) devices still require compliance by 26 May 2022.
In order to take advantage of these transitional timelines, manufacturers must have already issued a declaration of conformity to IVDD before May 26, will not introduce any significant design or intended use changes to the product after 26 May, have established a post-market surveillance and vigilance system in line with IVDR, and be registered economic operators in EUDAMED.
Therefore, even those organisations with devices in the above categories still have a number of obligations to fulfil from 26 May 2022. Where these requirements are not met, manufacturers must ensure they conform with the full requirements of the IVDR.
A consolidated version of the IVDR has been published that updates the original transition periods to be reflective of the January amendments.
We are awaiting the new guidance on significant changes for IVDs, which will help in determining if a change is considered to be significant and therefore whether or not it impacts the above caveats.
We strongly recommend that you continue to engage with a notified body as soon as possible, even if your products fall within the amended transition period. This is a process that could still take a considerable amount of time!