As of 26 May 2022, the In-Vitro Diagnostics Directive (PDF) will no longer be in effect. It will be replaced by the In-Vitro Diagnostics Regulation (IVDR), which will take immediate effect in EU member states on that date, after a five-year transitional period.
Under the IVDR, significantly more products than before will have to undergo a conformity assessment procedure with the involvement of a notified body. In order to ensure a smooth transition from the Directive to the IVDR, economic operators were granted a five-year transitional period expiring on 26 May 2022.
Under IVDR rules, about 80 percent of IVD manufacturers will be required to involve notified bodies in conformity assessment procedures for their products, compared to just about 15 percent under the IVD Directive.
This raises a unique problem: many of the notified bodies which were generally eligible for conformity assessment procedures under the IVD Directive have not (yet) undergone accreditation procedures in accordance with Article 31 et seq. of the IVDR and have no intention of doing so. At things stand (as of 6 August 2021), only five notified bodies in the EU are accredited in accordance with the IVDR and will have to conduct conformity assessment procedures under the IVDR . Under the Directive, there were most recently 18 accredited notified bodies. This will undeniably lead to delays in the certification of IVDs, which manufacturers must be prepared for.
In September 2018, the EU Commission published transitional rules (Implementation Rolling Plan) in order to ensure a smooth transition from the IVD Directive to the IVDR. But these transitional rules have created little relief as far as notified bodies are concerned.
The small number of notified bodies is particularly attributable to the fact that, until 26 May 2021, the competent bodies were also busy making preparations for the Medical Devices Regulation (MDR) and introducing the relevant structures. In order to avoid burdening them with both these tasks at the same time, the MDR was originally supposed to take effect on 26 May 2020, so that the competent authorities would have two years to make the necessary preparations for the entry into effect of the IVDR on 26 May 2022. But this time was shortened by one year because the entry into effect of the MDR had to be postponed by one year, to 26 May 2021, in light of the coronavirus pandemic and the associated challenges for the medical devices industry, while the entry into effect of the IVDR has yet to be postponed.
But the transitional rules do create a certain amount of relief as far as the Eudamed database is concerned. While Eudamed is not yet fully functional, so that not all relevant data can be published in the Eudamed database, manufacturers will be able to comply with their requirements even without publishing the relevant data in Eudamed. It is expected that Eudamed will be fully functional in 2022.
On the whole, it will be difficult to create adequate infrastructure for implementation of the IVDR by the time it enters into effect on 26 May 2022. It would appear sensible for the EU to postpone the Regulation’s entry into effect in order to ensure an adequate supply of urgently needed IVDs. Otherwise, there is a risk that the stricter requirements for conformity assessment procedures will hinder or delay development and placement on the market for a large number of IVDs due to a lack of notified bodies.
IVD manufacturers should seek to undergo conformity assessment procedures with accredited notified bodies right away, if they have not done so already, in order to ensure that their products receive the necessary conformity assessment by 26 May 2022. Otherwise, there is a risk that these products will have to be taken off the market.back