The Commission has issued a proposal for extending the transitional arrangements for the IVDR. This is not a simple unilateral extension so there are winners and losers.
The date of application remains the same, so IVDR vigilance and PMS requirements apply from 26 May 2022 for all devices on the market under IVDD and IVDR.
IVDs with an existing IVDD CE certificate benefit from an additional year added to their grace period, so IVDD certificates can be issued with a maximum expiration of 27 May 2025. However; new devices do not benefit from the extended transition. Class A non-sterile devices also do not appear to have been give any extension to the transition and would have to meet the requirements by 26 May 2022. This may be because there is no notified body role in the conformity route.
Only devices that have a declaration of conformity signed before the date of application are eligible for the proposed additional transition periods and during this time no significant changes can be made. If significant changes are required, the manufacturer would have to apply the IVDR.
Relief has also been provided to all stakeholders by granting a transitional arrangement to devices that do not currently have a notified body certificate but will need one under the IVDR. These grace periods are
- Class D devices - 26 May 2025
- Class C devices - 26 May 2026
- Class B devices - 26 May 2027
- Class A devices placed on the market in sterile condition.
There has also been an additional transition for laboratories based in Europe who are using the in-house exemption. They do not have to meet certain requirements till 26 May 2024 and justify unmet need till 26 May 2028; however, this does not address distance sales.
A word of caution, whilst this may look like the IVDR has been kicked into the long grass, it would be a huge mistake to think this way. The extensions enable the infrastructure to be put in place and for notified bodies to build capacity but also for manufacturers to complete their technical files and get them reviewed. The extension could make the IVDR achievable but there is no padding and no opportunity to take your foot off the gas I am afraid.
Finally, remember this is a proposal so it is important to track progress and any changes. Qserve has performed a more in-depth review, if you need help assessing how this impacts your company, please contact firstname.lastname@example.org.
Do you want to learn more on the current state of play of IVD?
Join our upcoming Free Webinar on November 16th in which Sue Spencer, Head of IVD, will share some real-world experiences from the IVDR CE marking process so that you can learn from the traps some manufacturers have fallen into so that you can use them as ladders to keep your applications on track.