Bowing to industry pressure, the European Commission announced a proposal to extend the transitional periods for the In Vitro Diagnostic Medical Devices Regulation 2017/746 ("IVDR"), whose Date of Application is 26 May 2022. The text of the amendment itself can be found here.
This is not the same sort of extension which we saw in relation to the Medical Device Regulation 2017/745 ("MDR") last year - there the Date of Application for the MDR was pushed back by a calendar year, essentially maintaining the status quo under the predecessor medical device framework for a little longer in response to the COVID-19 pandemic.
The IVDR Date of Application will still take place on 26 May 2022. What this proposal will do instead is amend the IVDR transitional provisions to give in vitro diagnostic medical devices ("IVDs") which have undergone conformity assessment before 26 May 2022 a little more time to remain on the market after the Date of Application.
Some brief points to note are:
- Notified Body designations under the old In Vitro Diagnostic Directive 98/79/EC ("IVDD") will not be extended - they will still become void on 26 May 2022.
- Certificates of conformity issued under the IVDD will expire at the latest on 27 May 2025, which is a year later than was originally the case under Article 110(2) IVDR.
- The introduction of certain provisions relating to the in-house exemption for healthcare institutions will be delayed1.
The main crux of this proposal is to completely replace Articles 110(3) and (4) IVDR to introduce a tapered transition period based on risk class for IVDs which will require a notified body conformity assessment for the first time.
Under the new Article 110(3):
- Devices with a certificate which remains valid after 25 May 2017 under Article 110(2) IVDR may be placed on the market or put into service until 26 May 2025.
- Devices for which the conformity assessment procedure pursuant to the IVDD did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body (so-called "up-classified" devices) may be placed on the market or put into service until the following dates:
- 26 May 2025 for class D devices;
- 26 May 2026 for class C devices;
- 26 May 2027 for class B devices;
- 26 May 2027 for class A devices placed on the market in sterile condition.
Devices placed on the market under this provision will need to continue to comply with the IVDD, save that they will need to comply with the requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices. They also may not undergo significant changes in design or intended purpose.
Under the new Article 110(4), devices lawfully placed on the market prior to 26 May 2022 will still be able to be made available or put into service until 26 May 2025. There is no change there. However:
- Devices with a certificate of conformity which is valid by virtue of Article 110(2) and Class D devices referred to in Article 110(3) will still be able to be made available or put into service until 26 May 2026.
- Class C devices referred to in Article 110(3) will still be able to be made available or put into service until 26 May 2027.
- Class A and B devices referred to in Article 110(3) will still be able to be made available or put into service until 26 May 2028.
Immediate thoughts and comments
It is welcome that the Commission has decided to take action to ease the transition to the IVDR. As we have written about many times previously, there has long been a serious lack of preparedness for the transition (especially with regard to notified body capacity to conduct conformity assessments) and other major figures in the life sciences industry have also been calling for action. We anticipate a rush of manufacturers seeking to refresh their certificates of conformity under the IVDD before 26 May 2022 in order to maximise the amount of time they can remain on the market for under the transitional periods.
However, this proposal is not a silver bullet. To begin with, it doesn't actually postpone the Date of Application. Manufacturers and other economic operators under the IVDR still need to be ready to comply with other obligations under the IVDR by 26 May 2022. Unhelpfully, the transitional provisions are drafted in such a way that it is difficult to tell precisely which obligations under the IVDR need to be complied with from that date. In this regard, the transitional provisions identify "the requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices". Without references to article numbers, it is difficult to tell exactly which legislative provisions in the IVDR fall under those headings, though we would assume that it is probably close to all of them. It would be sensible to assume that all obligations of economic operators will apply in relation to devices relying on the transition periods.
There are other consequences to extending the transition periods instead of postponing the Date of Application. It is positive that a great many devices which are already on the market will be able to remain on the market for longer under this proposal. However, this proposal will not help new devices which are currently seeking notified body conformity assessment - old notified body notifications will still become void on 26 May 2022, so there is very little time to conduct assessments against the IVDD in order to benefit from the transitional periods. Meanwhile, there is still a current lack of capacity to conduct conformity assessments against the IVDR.
Furthermore, much like the extension to the MDR Date of Application, this proposal amounts to kicking the can down the road. Unless there are serious efforts made in the time that this proposal will buy to markedly increase notified body capacity, we will most likely find ourselves in exactly the same position in a year or more as the revised transitional periods start to wind down.
Finally, this is just a proposal. It may not in fact go anywhere and we may be stuck with the current IVDR transitional periods for good. However, that would be surprising given that the MDR has already set a precedent for this sort of intervention. Moreover, the Council of the European Union has itself called on the Commission to introduce a legislative solution of this sort2. In all, this proposal is a very good thing that will most likely save lives, but we are not out of the woods yet.
1. For those interested, Articles 5(5)(b),(c),(e) and (i) will apply from 26 May 2024 instead of 26 May 2022. Article 5(5)(d) will apply from 26 May 2028.
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