The new EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) is affecting IVD manufacturers but also diagnostic laboratories in a severe manner. Many laboratories depend on affordable CE-IVDs which might (temporarily) not be available due to stricter requirements and the delayed set-up of the regulatory framework (e.g. insufficient capacity of notified bodies). To guarantee the best medical care for their patients, some laboratories are using in-house devices (IH-IVDs, often referred to as LDTs). For those laboratories article 5(5) is the most relevant article in the IVDR. It states that with the exception of the requirements set out in article 5(5) this regulation shall not apply to devices manufactured and used only within health institutions established in the Union. These requirements include i.a. the compliance with a proper quality management system (5(5b+c)) and a justification that the target patient group´s specific needs cannot be met at an appropriate level by an equivalent device on the market (5(5d)). It is worth mentioning, that the IVDR lacks definitions for e.g. “equivalent” as well as for “patient specific needs”. In December 2021 an amendment for staggered, extended transition timelines for CEIVDs and IH-IVDs was adopted. The transition timelines for legacy CE-IVD are extended based on the risk class to May 2025-2027. This extension is welcomed as it helps to safeguard continuous patient care by reducing the risk of disrupted supply chains. The new transition timelines for IH-IVDs are independent from the risk class but apply to specific subpoints of the article 5(5). Whereas 5(5d) only becomes applicable in May 2028, the fulfilment of other requirements (5(5b,c;e-i) is postponed until May 2024. Please note that the remaining requirements described in article 5(5), e.g. fulfilment of the general safety and performance requirements (annex I) are applicable from May 2022 on. To build a bridge between the laboratories and the official bodies, the BioMed Alliance, a unique organisation representing 36 leading Biomedical Societies in Europe, gathers information, raises awareness and shares concerns. The status of the preparedness as well as concerns of laboratories all over Europe was recently evaluated in a questionnaire. There are various activities to help laboratories to understand and comply with the IVDR requirements. E.g. the European Scientific foundation for Laboratory Hemato Oncology (ESLHO) has collected a lot of valuable information all around the IVDR. Also, the Ad hoc Commission IVD of the Association of the Scientific Medical Societies in Germany (AWMF) generated guidance documents as well as templates that are freely available to support laboratories.

With the introduction of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in 2017, the European legal framework for in vitro diagnostic medical devices was fundamentally revised. The aim was to create a solid, transparent and predictable as well as sustainable legal basis, which also ensures a high level of safety and health protection and at the same time promotes innovation. In order to do justice to these principles, a focussed implementation of the IVDR that does not lose sight of the practical realities is required, especially at the present time. Unfortunately, it is not possible to speak of a smooth transition from the old legal situation under the IVDD to the IVDR. The creation of staggered transition periods through Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 is welcome. The low number of Notified Bodies under the IVDR so far will nevertheless have a painful impact on the market at various levels. The transfer of existing products in accordance with the new transitional regulations will not only tie up capacities in the short term, but also on a large scale in the long term. Bottlenecks are already becoming apparent here. It must be taken into account that not all manufacturers already have contracts with Notified Bodies. The resources tied up at the Notified Bodies (and also at the manufacturers) for handling existing products are also lacking elsewhere: Innovations are in danger of falling behind. The IVD sector is extremely innovative; more than 10 percent of the turnover is spent on research and development. At present, it is extremely difficult to place new products on the market and manufacturers cannot plan with any certainty. For manufacturers without a notified body, market access for new products is effectively blocked. A specific problem also arises with the newly created transitional regulations for products that will be assigned to class D in the future. Here, the comparatively shortest transitional period (until May 2025) is contrasted by the longest conformity assessment procedure (approx. 16-24 months). The reference laboratories required for this have not yet been named. A similar problem exists with companion diagnostics.

Regulation EU 2017/746 (IVDR) significantly increases the involvement of Notified Bodies in the assessment of In-Vitro Diagnostics medical devices (IVDs) in the European Union. It is estimated that >80% of the IVDs currently on the EU market will require a conformity assessment by a Notified Body under the regulation. Furthermore, for class D devices, the conformity assessment is complemented with an additional performance verification by an EU reference laboratory if available and, if certification and no Common Specifications exist for that type of device, by a view of the IVD Expert Panel. The IVDR Date of Application is 26th May 2022, however following the publication of Regulation 2022/112 on January 25, 2022, the transitional provisions of the IVDR have been modified allowing for longer transition times for existing devices under certain conditions. Nearly one month after the IVDR Date of Application, this presentation will review the status of the regulatory infrastructure required for the successful implementation of the IVDR and the impact of regulation EU 2022/112 from a Notified Body perspective.