The EU has already in December 2021 extended the transitional periods for Regulation 2017/746 on in vitro diagnostic medical devices (IVDR), as announced in this press release. But this does not change the date of application of the regulation. This remains May 26, 2022. However, the new deadlines give manufacturers and notified bodies a little more time to get their IVD devices through the conformity procedure. In a further amendment by the European Commission in March 2023, the sell-off deadline no longer applies.
As a result, the new regulations could, among other things, prevent IVDs from disappearing from the market en masse and safe devices from being unnecessarily discarded.
Read on to find out what the new deadlines are and what they mean for you.
Above all, the amendments give manufacturers of devices that require the involvement of a notified body according to the IVDR more time. These devices may still be manufactured and placed on the market after May 26, 2022. But be careful! Some IVDR requirements still have to be met. You can read more about these below.
First, it is important to note that the new regulations only apply to legacy devices. These are devices for which compliance has been (or still will be) declared before May 26, 2022 AND are in classes D, C, B or A (sterile) according to the IVDR. This means that all devices benefit from an extended transitional period, except:
The length of the new transitional periods depends on the future risk class and whether a notified body has previously been involved under the IVDD.
The following diagram summarizes the regulations. The following section explains in detail how this will work in individual cases.
For in vitro diagnostic medical devices for which a certificate has been issued by a notified body under the IVDD, the deadline in Article 110(2) is changed as follows:
Example: Let's assume you have declared conformity for a List B IVD with a certificate from a notified body according to Annex IV of the IVDD (full quality assurance system). The certificate bears an issue date prior to May 25, 2017. Then the validity date should be shown on the certificate up to a maximum of May 25, 2022, because that is the requirement of the IVDD (Article 9 (10)). Therefore, anyone who does not receive a current certificate for their existing products under IVDD from the notified bodies by May 25, 2022, at the latest, must declare conformity under IVDR. To do this, manufacturers must involve a notified body accredited for the IVDR. With a certificate now issued between May 25, 2017, and May 25, 2022, the certificate validity must end no later than May 26, 2025 (the last possible date); otherwise, it will become invalid per IVDR Regulation Art. 110.
The prerequisite for this case is that a notified body is or was already involved in the conformity assessment procedure under the IVD Directive 98/79/EC. Otherwise, no certificate of a notified body can exist.
Devices that receive such a certificate are devices that comply with Annex II, List A, and List B or self-tests, regardless of the chosen conformity assessment procedure under the IVDD. Thus, it does not matter whether the device in question has received a certificate under IVDD via a full quality assurance system, via type examination, or via design examination in the case of self-tests.
If we take the example of a declaration of conformity that has been or will be issued according to Annex III of the IVDD without the involvement of a notified body before May 26, 2022, the question is which IVDR class the device will fall under in the future.
If you want to use this option, you should pay attention to the details in the declaration of conformity. This article will help you with this:
I) If the device will be in class D in the future, then you can continue to manufacture and place the device on the market until May 26, 2025 but you cannot modify it. After that date, you or the distributor may continue to provide and put the device into service, as the so-called "sell-off rule" does not apply.
II) If the device will be in class C in the future, then it can continue to be manufactured and placed on the market until May 26, 2026. Substantial modifications are not permitted.
III) If the device falls into class B or A (sterile), the manufacture and placing on the market of the device is permitted until May 26, 2027, which makes this the longest transitional period. Modifications to the device are not permitted in this case either.
However, the extensions proposed by the Commission do NOT apply to two device groups:
If the device will fall into class A in the future and is not a sterile device, manufacturers must provide proof of conformity according to the IVDR from May 26, 2022 in all cases and comply with all applicable requirements of the IVDR. This means they cannot take advantage of any extended transitional periods. As no notified body is required, being able to do this is reliant only on the manufacturer's resources and scheduling.
Similarly, the extended deadlines do not apply for “new” in vitro diagnostic medical devices. The Commission considers in vitro diagnostic medical devices whose conformity has not been declared under the IVDD as “new” devices.
For these devices, manufacturers will also have to demonstrate conformity according to the IVDR from May 26, 2022 in all cases.
There is now some more leeway for devices produced and used by health institutions themselves. The main purpose of this extra leeway is to relieve the burden on health institutions, such as laboratories, that have been hit hard by the coronavirus pandemic.
But beware, the following requirements remain unaffected:
3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
4. Devices that are manufactured and used within health institutions shall be considered as having been put into service.
5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met
The first sentence of Article 5 (5), the second sentence under (a), and the third to fifth sentences shall also remain unchanged.
Therefore, from May 26, 2022, all lab developed tests in the EU must meet the general safety and performance requirements set out in Annex I of the IVDR, including the performance evaluation, and may not be provided to another legally independent facility – legal requirements that are already established in Germany in the Medizinproduktegesetz (MPG).
Article 5(5) of the IVDR establishes longer deadlines for specific LDTs in its subsections. The deadline for the implementation of subsections (b) and (c), and (e) through (i), is now May 26, 2024. For d), the deadline is now May 26, 2028.
The latest deadline is for d). It states:
“the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market”
This requirement was intended to ensure that there is no market competition between LDTs and commercial devices, since they are regulated differently. Now the EU has moved this issue right to the end of the transitional period with the reasoning that laboratories will only be able to compare the devices on the market with their own devices when all IVD devices on the market have been authorized under the IVDR and registered in EUDAMED.
The following items in Article 5(5) are granted a two-year postponement until May 26, 2024:
As it stands to date, the deadline for EUDAMED registration of IVDs is November 26, 2023.
This follows from Article 26(3) IVDR as well as Article 113 IVDR, which refers to it. Art. 113 IVDR also refers to the fact that IVDs must be registered in EUDAMED 18 months after the date of application of the IVDR.
The IVDR will apply from May 26, 2022. Therefore, the post-market surveillance obligations established in Articles 78 to 81 and the vigilance obligations (Articles 82 to 87) and the specifications regarding monitoring by competent authorities also apply, regardless of the transitional periods. Therefore, all of Chapter VII of the IVDR applies, even if the device was placed on the market under the IVDD. In addition, economic operators must register in EUDAMED.
However , the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to […] instead of the corresponding requirements in Directive 98/79/EC.
EU Commission proposal of October 14, 2021 to adapt the IVDR (EU) 2017/746
The notified body that issued the certificates under the IVDD will continue to be responsible for monitoring conformity during the transitional period.
It is important that no substantial modifications are made to the devices during the transitional period because otherwise manufacturers will have to apply the IVDR in full immediately.
The IVDR entered into force on May 25, 2017 and is scheduled to become mandatory on May 26, 2022. The new deadlines do not change this. The previous deadlines would have made a high proportion of the declarations of conformity issued under the IVDD invalid from May 2022.
However, on October 15, 2021, the EU Commission published a proposed amendment to the IVDR to give manufacturers more time to go through the conformity assessment procedure. The resulting amending regulation has passed through the legislative process very quickly, as did another proposed amendment in January 2023 that eliminated the "sell-off" provision.
The Commission primarily justified its proposal based on the impact of the coronavirus pandemic: the pandemic has tied up a lot of resources, making it almost impossible to implement the necessary measures quickly.
However, the impact of the MDR on the medtech market is also likely to play a role. The aim is to avoid the kind of device culling caused by the MDR with in vitro diagnostic medical devices. Various actors have been sounding the alarm for months already.
The Commission also recognized the urgency of the situation in its proposal:
The IVDR will apply from May 26, 2022. The new regulations in the IVDR do not change this fact. However, a significant number of IVD manufacturers will now be given more time to demonstrate their device's conformity. Given the current shortage of notified bodies for the IVDR and the generally fraught situation due to the coronavirus pandemic, this should be a big relief for a lot of manufacturers – and help keep important IVDs on the market. In addition, unnecessary disposal of safe devices is now prevented. For medical laboratories, too, some requirements now apply with a time delay. Nevertheless, they must also meet the basic safety and performance requirements for in-house devices and lab-developed tests.
Twenty-two days before the effective date of the IVDR, the MDCG has published a new guideline, MDCG 2022-6, which is intended to provide clarity on the concept of "substantial changes in design and intended purpose" under Article 110(3) of the IVDR. As such, the guideline is particularly relevant for manufacturers of IVDD-compliant devices that will still be placed on the market or put into service after May 26, 2022. The guideline is based on the MDCG 2020-03 guideline published in March 2020.
The MDCG first fixes what are not "significant changes." This includes, in particular, administrative changes and organizational changes - closely aligned with MDCG 2020-03. It goes on to define "substantial changes in design and intended purpose." Here, reference is made to the six flowcharts in the Appendix, and specific examples are provided.
If you, as an IVD manufacturer, have already dealt with MDCG 2020-3, MDCG 2022-6 is not a big surprise. However, the concrete examples from Chapter 220.127.116.11 onwards provide added value.
Our strategic experts at the Johner Institute will be happy to assist you with any questions you may have regarding IVD regulatory strategy or, specifically, Lab Developed Tests.