IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house produced devices) due to my enthusiasm to get the news out quickly. In the mean time I have fixed these in the text of the blog post. If you have been emailed the text of the initial post about the proposal in the normal blog mailing, please check again on this blog online for the latest (and now accurate) text.

Legislative procedure progress

In the mean time the IVDR amendment proposal has been flying under the radar in an accelerated legislative procedure that will take a major step in the  Employment, Social Policy, Health and Consumer Affairs Council (EPSCO Council) meeting on 6-7 December, where the proposal will be summarily dealt with under the heading of other business. The Council has decided not to amend the text proposed by the Commission and will therefore approve the EP’s first reading position in case it would also decide to adopt the regulation as put forward by the Commission. Obviously this is important information because this basically fixes the final text of the amendment unless the Parliament is going to propose amendments, which would slow down the proposal considerably.

At this time I know that the Parliament’s ENVI Committee has been looking at the proposal but has not taken a decision yet on first reading. This means that the eyes are on the ENVI Committee because at Council level the proposal is a done deal and the text could be adopted very quickly now.

Grace periods and sell-off periods

In the mean time I’ve had the opportunity to look a bit more closely at the stacked grace periods set up under the proposal under amended article 110 (3) IVDR, which graphically look as follows:

Grace periods and sell-off periods under IVDR proposal

As you can see above the stacking involves stacked grace periods in all cases except class A non-sterile devices – they have to meet the IVDR requirements in full as of 26 May 2022, which remains the date of application for the IVDR.

The year-extra sell-off period for devices placed on the market lawfully during the grace period, which we know from the MDR has been implemented in the IVDR for the respective grace periods, except that this did not lead to an additional year in the case of devices with an IVDD CE certificate, these could already be sold off until 26 May 2025 under current article 110 (3) IVDR.

In-house produced devices

In the mean time the amendments to Article 5 (5) IVDR (in-house produced devices – often but inaccurately referred to as LDTs) are hotly debated, because contrary to what many health institutions / labs (still) believe not all requirements of Article 5 (5) IVDR are delayed (see my previous post about the proposal for more detail on the delays proposed for certain, but not all requirements).

The introductory paragraph of Article 5 (5) (GSPRs in Annex I apply), Article 5 (5) (a) (no transfer between legal entities) and the final two paragraphs of Article 5 (5) regarding competent authority oversight and the prohibition to manufacture at industrial scale will apply immediately as of the date of application of 26 May 2022, without grandfathering. 

National requirements on reporting and possible prohibitions on certain categories of in-house devices can kick in as of that date and health institutions should make sure that they are aware of those.

No delay!

For those that were still hoping that the IVDR would be delayed, now is the time that this will not happen. At best your device is subject to a grace period or for the in-house produced devices a partial exception to the requirements, which gives you more time to transition and to spread resources, but the date of application is firm. Given the persisting lack of notified bodies for the IVDR and the relatively large amount of IVDs needing a first CE certificate compared to available notified body capacity, there is no time to sit on your hands during the grace period, or even before the date of application, as I have often written on this blog.


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