For manufacturers, the change from the IVD Directive 98/79/EC (IVDD) (PDF) to Regulation 2017/746 (IVDR) (PDF) means, among other things, that a large number of their products will be subject to new classification rules. This makes it necessary to involve a Notified Body in the conformity assessment procedure for approx. 80% of products. Under the IVDD, this was the case for only about 15% of in vitro diagnostic (IVD) devices. At the same time, the number of Notified Bodies that can demonstrate accreditation for IVD has decreased. As of 5 January 2022, there are exactly 6 Notified Bodies listed on Nando.
It is therefore clear that when the IVDR comes into force on 26 May 2022, a large proportion of IVDs will not be able to be placed on the market in conformity with the IVDR due to a lack of sufficient capacity on the part of Notified Bodies. In fact, it has not yet been possible for a large number of manufacturers to carry out a conformity assessment procedure for their product that meets the requirements of the IVDR with the involvement of a Notified Body. There is a threat of a supply shortage of IVDs, which, at minimum, could affect SARS-CoV‑2 testing.
New transition periods – Commission proposal
In view of this situation, the EU Commission published a proposal (PDF) for an amendment (PDF) to the IVDR in October 2021, which was aimed at extending the transition periods from the IVDD to the IVDR and has since been adopted by the EU Parliament and Council. According to the implemented proposal, IVDs placed on the market and certified according to the previous rules of the IVDD should be able to continue to be placed on the market and sold. Depending on the risk class, the new transition periods for placing the products on the market will end on 26 May 2025, 2026 or 2027. The sell-off rule allows the sale of products already placed on the market for a further year after the end of the respective transitional period.
The new rules affect products in inventories,
1. for which conformity according to IVDD was already declared before 26 May 2022, and
2. that fall under classes D, C, B or A (sterile) in accordance with the IVDR.
New deadlines do not apply to all IVDs
Conversely, the new rules do not apply to products
1. for which a declaration of conformity will not be issued until 26 May 2022 or
2. which fall under Class A (non-sterile) in accordance with the IVDR.
The following is therefore certain: For manufacturers of non-sterile IVDs subject to Class A in accordance with the IVDR, the deadline of 26 May 2022 is set in stone. It is mandatory that their products be IVDR compliant by the deadline. Since the involvement of a Notified Body is not foreseen for the conformity assessment of these products, the timely and proper implementation of a corresponding conformity assessment procedure does not depend on the manufacturers’ success in gaining the support of one of the few accredited Notified Bodies. Consequently, manufacturers do not benefit from the extended transition period. This also applies to new IVDs the conformity of which has not yet been declared in accordance with the rules of the IVDD. For these “non-stock” products, too, the effective date of the IVDR on 26 May 2022 is binding and cannot be “postponed” any further.
Date of application of the IVDR remains unaffected
It is important to emphasise that despite the new transition rules, there is no change to the basic effective date of the IVDR as of 26 May 2022. This affects the obligations of manufacturers for product monitoring and vigilance, but also the monitoring by the competent authorities: The rules of the IVDR apply to all products, regardless of whether or not they are still IVDD-compliant and have been placed on the market in accordance with the new transition periods.
In addition, similar to the rules of the MDR, no further significant changes may be made to the products themselves or their intended use within the transition period. If changes are made, manufacturers are obliged to make the products fully IVDR-compliant.
Recommendation for action
With the extended transition periods, the requirement to place IVDs on the market in conformity with the rules of the IVDR has not been removed, but merely postponed. In addition, the transition periods do not apply to all products or to all regulatory content of the IVDR. If they have not already done so, manufacturers should therefore obtain an overview of the applicability of the transition periods in relation to their product portfolio and also make every effort to implement the requirements of the IVDR as quickly as possible, irrespective of the classification of their IVD.back