In Vitro Diagnostic Regulation (IVDR)
Existing requirements established by the IVDD have not been removed, but the IVDR adds new ones. Among the main changes are:
- The introduction of a unique device identifier (UDI) for each IVD device, that allows the unique identification of a product in the market.
- The devices can be classified into four classes (A, B, C, and D) based on their intended use and inherent risks.
- An increase in notified body (NB) inspections. Product classification requires NB approval, with the exception of class A nonsterile.
- Clinical evidence is continuously reassessed throughout the lifecycle of the device to ensure safety and performance.
- The IVDR will reduce the risks of discrepancies in interpretation across the EU market, since regulations do not need to be transposed into national law.
Our team has been preparing for these changes since the very beginning:
This year Vircell has been audited by the notify body TÜV SÜD to obtain the ISO 13485, which certifies our quality control system. We’ve also developed a BiDi format for the UDI that is being implemented on the product labels. Furthermore, all of our class A products are in compliance with the IVDR since 26 May 2022.
In this regulation the devices are divided into classes A, B, C and D, depending on the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII:
- Class A: Low individual risk and low public health risk. For example: Products for general laboratory use.
- Class B: Moderate individual risk and/or low public health risk. For example: Devices intended for the detection of Candida albicans.
- Class C: High individual risk and/or moderate public health risk. For example: Devices intended for the detection of Neisseria gonorrhoeae.
- Class D: High individual risk and high public health risk. For example: Devices intended for the detection of diseases with high propagation risks.
If several classification rules apply to the same device, the higher classification will be applied.
In Vircell, we’ve been working hard to keep almost all of our products available for you. Right now, we have more than 450 references in our catalogue and they will be in compliance with the IVDR according to the schedule for each class.
Manufacturers should be responsible for the conformity assessment procedure for class A devices. This is because these devices suppose a low risk to patients, unless they are sold sterile. Class A sterile, Class B, C and D devices, have to be reviewed by a notified body.
Vircell chose TÜV SÜD (Product Service GmbH) as the notified body responsible for the assessment. Right now, we have the ISO 13485 certification with TÜV SÜD that certifies Vircell quality control system in compliance with the IVDR which is a requirement to mark products as CE.
The amendment of the transition periods proposed by the European Commission only changes the dates of application of some IVDR requirements for certain medical devices. The effective dates are as follows:
- Class A nonsterile: They must be in compliance with the IVDR since last May 26, 2022.
- Class B and A sterile: Enters into force on May 26, 2027.
- Class C: Enters into force on May 26, 2026.
- Class D: Enters into force on May 26, 2025.
In these transitional periods, the notified body review process could last longer than 6 months. As we mentioned, class A nonsterile products are self-certified and have already transitioned to IVDR on May 26th (download our list). For the rest of classes that require a conformity assessment, the time depends largely on their class.
Since October 18 we have obtained the necessary certification to mark our class B and C products according to the IVDR. This certification was granted by the notified body TÜV SÜD Product Service GmbH. At the moment, a large part of our CE marking corresponds to the IVDD.
They will be marked as research use only (RUO). In this list you can find all the products now marked as RUO by line. As you can see, we added the letter -R to their reference so you can easily identify them.
Furthermore, our cell lines are now marked as general laboratory materials since they are meant to be used together with an IVD device that performs the diagnostic. This change will not affect their quality or efficiency.