Commercial readiness in light of In Vitro Diagnostic Regulation (IVDR)

There is no question that the new European In Vitro Diagnostic Regulation (IVDR) is complex and will have far-reaching implications. How ready is your business for the implementation of the new regulations? Do you know what the role of your organization is, as defined by IVDR? Understanding and analyzing your product portfolio will highlight what you need to discuss with suppliers and subcontractors to ensure you develop a robust supply chain to maintain continuity.

Our previous webinar, ‘Getting ready for IVDR’, helped equip you with information to draw up an action plan. In this webinar, our panel of experts discuss the commercial considerations in more detail. We examine the new responsibilities of economic operators, whether your product is an IVD according to IVDR classification, and explore research use only vs general lab use in relation to IVDs.

Read on for highlights of the live Q&A session or register to watch the webinar at any time that suits you.

Q: What information will the notified body want to see about the instrument in the reagent technical file? For example, will the notified body want to see the near-patient studies performed on the instrument? Will they want to see any other data for the instrument?

JS: I will go to the essence of the regulation. In the case that your instrument is a Class A device, the instrument or the software running the instrument does not perform any form of analysis, or so on. For the reagent, we will look at the performance of the reagent according to the way it has to be used. If you look at the performance evaluation that you must perform, you have the scientific validity, the analytical performance, and the clinical performance.

The clinical performance must be the use of your device, your reagents, within the intended purpose, with the intended users and in situ. In this case, it will be running on your device. Therefore, we do not have to have part of your evaluation of the instrument, but we will have to see that the performance has been carried out on that instrument, and that will be the way they will evaluate how the performance was done. In addition, we need you to describe your reagent, and whether it has to be used with that specific analyzer or instrument — then it's important for you to identify that instrument.

Q: If we have a vigilance case or field action that relates to the legacy instrument post May 2022, would we have to report? Should the strategy for legacy devices be documented in the strategy for regulatory compliance article 10 8A?

EV: Yes, if it is a legacy device, which is on the market post the date of application, then the vigilance requirements still apply. If it is a legacy device in the way that the legacy device term is used — that means a device with a pre-date of application CE certificate that is on the market between 2022 and 2024, under Article 110 Section 3 of the IVDR — then, you need to engage with vigilance by the IVDR standards, because that is one of the requirements in Article 110 Section 3.

The strategy for regulatory compliance will be based on the old device. Since you have not CE-marked the device under the Medical Device Regulation (MDR), the regulatory compliance will be based on ISO 13485.

Q: Would the notified body expect a separate Summary of Safety Performance (SSP) for a reagent cartridge and another for the associated controls? As the data to support the performance of the devices has been performed as part of the same study, can these be combined into one technical file?

JS: There will be an SSP guidance coming for IVD. Whatever I might say here could change, depending on the guidance that will come out. If you look at the basic Unique Device Identification (UDI) and how that basic UDI device identifier (UDI-DI) is associated. One of the elements must be the same intended purpose, the same manufacturing processes, and the same class. If you look at all of those and you consider, this is only in the case where calibrators and control are associated with the product, they must have the same class as the reagent. If the calibrators and control are associated with the product, the reagent must be the same.

If you talk about a difference in the assay and the control, they will have to have their own SSP. However, if you talk about the one that goes with an assay, then they basically have the same class. If we base on that principle, they may also have the same basic UDI-DI, and in that case, they will be combined. If there is a big difference and you used the UDI on an assay control, the control will have a life of its own. Therefore, it does not matter if they are together or not and that is the way I see it today.

Find out how to best adapt to the latest European In Vitro Diagnostic Regulations>>