New IVDR Transitional Periods

2. The new deadlines in detail

a) IVDs for which a certificate has been issued by a notified body under the IVDD and that also require a notified body under the IVDR

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:

• Certificates issued by notified bodies under the IVDD prior to May 25, 2017 will remain valid until the date indicated on the certificate. So, for these devices, there is no change.
• Certificates issued in accordance with Annex VI of the IVDD will become void at the latest on May 27, 2025.
  (Previously: 2024 – 1 year extension)
• Certificates issued by notified bodies in accordance with the IVDD from May 25, 2017 will become void by May 27, 2025 at the latest.
  (Previously: 2024 – 1 year extension)

What specifically does this mean?

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.

b) “Other IVD devices” placed on the market under the IVDD and that require a notified body under the IVDR

• For in vitro diagnostic medical devices for which manufacturers issued the declaration of conformity themselves without the involvement of a notified body before May 26, 2022 and which, under the IVDR, must undergo a conformity assessment procedure with the involvement of a notified body according to the IVDR classification rules, the following new transitional periods apply:
  • May 26, 2025 for class D IVDs
  • May 26, 2026 for class C IVDs
  • May 26, 2027 for class B IVDs
  • May 26, 2027 for class A IVDs placed on the market in sterile condition

• Therefore, depending on the risk class of the IVDs, these legacy devices can continue to be placed on the market after the IVDR starts to apply on May 26, 2022, provided that the devices comply with the requirements of the IVDD and there are no significant changes to the design and intended purpose. 

• However, manufacturers should be aware that even for devices for which the proposed transitional periods would apply, the requirements of the IVDR with regard to post-market surveillance (PMS), market surveillance, vigilance and registration of economic operators and devices must still be complied with.

What specifically does this mean?

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.

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.

C) No extension for “normal” (non-sterile) class A devices and “new” IVDs

However, the extensions proposed by the Commission do NOT apply to two device groups:

• “Normal” (non-sterile) class A devices
• “New” IVDs

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.

d) Laboratory developed tests (LDT)

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: 

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:

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.

Why the EU has granted a postponement for LDTs

The following items in Article 5(5) are granted a two-year postponement until May 26, 2024:

• Quality management system
  Letter b) establishes the requirement for an appropriate quality management system that must, at least, take into account ISO 13485 for IVD device development and manufacture in order to comply with the state of the art.

• Quality assurance in the laboratory
  Letter c) requires compliance with the specifications of ISO 15189 for quality assurance in the laboratory and compliance with national accreditation regulations, e.g., RiLiBÄK (Guidelines of the German Medical Association for Quality Assurance of Medical Laboratory Tests) in Germany.
• Provision of information
  Letter e) requires the provision of information to authorities on manufacturing, modification and use.
• Public declaration
  Letter f) requires compliance with Annex I of the IVDR.
• Documentation
  Letter g) relates to the documentation on production, design and performance, in other words the “device file.”
• Proof of manufacture according to the specifications (batch record)
  Letter h) requires proof that all devices are manufactured according to the specifications in the “device file.”
• Serious incidents and corrective actions
  Letter i) requires the collecting and reviewing of experiences gained from clinical application use, as well as the taking any necessary corrective actions.

e) EUDAMED 

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.

3. What has not changed

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.

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.

4. Background of the changes

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.

Reasons

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.

• Several stakeholders from politics, the medtech industry and notified bodies, as well as medical professionals, scientists and non-profit organizations have warned of the dangers of the too-short deadlines in the IVDR.
• On May 11, 2021 and June 15, 2021, respectively, various parties and the Council of Health Ministers approached the Commission to request a new regulation.

The Commission also recognized the urgency of the situation in its proposal:

• At the time of the proposed amendment in 2021 there were only six notified bodies in the whole of Europe that can work with the IVDR (there were 18 under the IVDD).
• At the same time, notified bodies now have to be involved with a considerably higher number of in vitro diagnostic medical devices: previously, their involvement was needed for about 8% of IVDs on the market. Under the IVDR, just under 78% (approx. 24,000 IVDs in total) would require the involvement of a notified body.
• According to a survey by MedTech Europe, if the deadlines were not extended, from 2022, around 22% of in vitro diagnostic medical devices would disappear from the market (there are currently approximately 40,000 IVDs on the market, i.e., 9,000 would disappear).
• However, Covid-19 has shown just how important reliable in vitro diagnostic medical devices are.
• Around 70% of clinical decisions are taken with the help of in vitro diagnostic medical devices.
• The proposed amendment in 2023 adds the following: To avoid unnecessary disposal of safe medical devices and in vitro diagnostic medical devices still in the supply chain, which would further increase the immediate risk of shortages, such continued provision of devices should be without time limit.

5. What the changes mean for manufacturers

• Therefore, it is important that manufacturers stick to their implementation plan to ensure that their IVDs become IVDR-compliant in time.
• Manufacturers should not waste any time, particularly in light of the scarce resources.
• Manufacturers should be clear about the risk class of their IVD. It’s not just the conformity assessment procedure that depends on it, the transitional period does as well.

6. Conclusion

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.

7. Further reading 

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.  

Conclusion 

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 4.3.2.1 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.