altona Diagnostics’ approach to the IVDR

Everything you need to know

 

The IVDR and altona Diagnostics
The IVDR will become fully applicable by May 26, 2022. altona Diagnostics is ready.

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Amendment to the IVDR
Extended transition periods for products CE-marked under the IVDD have been accepted by the EU: IVDD products can be placed on the market until May 26 of 2025, 2026 and 2027, respectively, depending on the IVDR risk classification of the product.

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altona Diagnostics product portfolio and the IVDR
AltoStar® and FlexStar® products will be fully IVDR compliant and be available as IVD products for the foreseeable future.

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Extended availability of RealStar® products
Most RealStar® products will be offered as IVDD products until the respective transition period according to IVDR risk classes ends.

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Steps to IVDR compliance
At all times, customers will receive IVD products from altona Diagnostics, which are fully compliant with the applicable regulations.

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FAQs
altona Diagnostics and the IVDR.

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The IVDR and altona Diagnostics

The IVDR

Laboratories all over Europe are affected by immense regulatory changes applying to diagnostic devices and laboratory-developed tests (LDTs). The upcoming in vitro diagnostic regulation (IVDR, (EU) 2017/746) entered into force in 2017 and will supersede the in vitro diagnostic directive (IVDD, 98/79/EC) with full applicability by May 26, 2022. However, prolonged transition periods were established for IVDD products.

 

The new regulation will head the diagnostic market towards an increase in transparency, comparability, robust results, and reliability, respectively. The combination of these improvements will be beneficial to patients, clinicians, and laboratory professionals alike.

 

altona’s stance

Among the changes introduced by the IVDR, for example, the increased involvement of notified bodies, a new risk classification system, and enhanced post-market surveillance and transparency. Therefore, altona Diagnostics has forcefully combined capacities for years to develop products corresponding to the IVDR. We are converting our AltoStar® and FlexStar® products into IVDR compliant versions.

Amendment to the IVDR

 

Extended transition periods

The diagnostic market is facing major changes with the advancing timeline to the full applicability of the IVDR. In the advent of the tremendous shift, the European Commission composed a proposal to the IVDR in 2021. The suggestions were approved by the European Parliament and the EU Council. The proposal has led to an amendment to the IVDR, which provides updated transition periods.

 

Although the requirements of the IVDR remained unaffected, the following aspects apply with the publication of the Official Journal of the EU on January 28, 2022:

  • Full applicability of the IVDR by May 26, 2022
  • IVDR transition periods for IVDD products are extended according to the IVDR risk class
    • Future class D products benefit from a transition period placing IVDD products on the market until May 26, 2025 (e.g., highly pathogenic viruses, Lassa virus, Ebola virus, SARS-CoV-2, HIV, HBV, HCV)
    • Future class C products benefit from a transition period placing IVDD products on the market until May 26, 2026 (e.g., most other pathogens, herpes-/polyomaviruses, HAV, HEV, WNV, DENV, CHIKV, Plasmodium species)
    • Future class B products benefit from a transition period placing IVDD products on the market until May 26, 2027 (e.g., norovirus, rotavirus, non-pandemic influenza A/B virus, RSV, hMPV)
  • Future class A products will have to be IVDR compliant until May 26, 2022.

 

altona’s stance

As the consequences of the COVID-19 pandemic are intensively impacting all parts of the healthcare sector, altona Diagnostics perceives the transition periods of the amendment to the IVDR as positive, retaining both high-level quality and unrestricted availability of diagnostic products, e.g., PCR assay kits. Despite the extension of IVDR transition periods, altona Diagnostics has already taken action to convert our product portfolio to IVDR compliance.

altona Diagnostics product portfolio and the IVDR

Overview 2022–2023

 

 

Details 2022-2027 and beyond

 

altona Diagnostics is committed to provide IVDR-ready products to our customers to facilitate early adoption of the new requirements. We have focused on the approach of launching AltoStar® products, which we have designated as “CE: IVD 2022”. However, the "CE: IVD 2022" products comprise a technical documentation that is prepared to meet the requirements of the IVDR. These products combine the AltoStar® Molecular Diagnostic Workflow with the usability of other workflows (manual or automated) and, in this way, are “open workflow” compatible.

 

The AltoStar® product line is already available as “CE: IVD 2022” and all upcoming products of the new FlexStar® product line will also be available as “CE: IVD 2022”. These products are aimed to be IVDR compliant in 2022 certified by the notified body. Given that the IVDR will gain full applicability by May 26th, 2022, our products of the future risk class A will have to be IVDR compliant. Therefore, we will conduct the necessary activities to take this into account. This will affect the AltoStar® Purification Kit 1.5, the AltoStar® Whole Blood Pretreatment Buffer 1.5, and the FlexStar® (RT-)PCR Amplification Mix 1.5.

 

 

 

Maintaining the transition of the “non-open” workflow we intend to fulfill the last shipments of the “non-open” AltoStar® versions in spring of 2022. Please note that the “non-open” AltoStar® products will eventually be discontinued underlined by the last kit lot expiry date of January 31, 2023. Moreover, our RealStar® product versions 1.1/1.2 (designed for use with the capillary LightCycler® instruments 1.2/1.5/2.0 and the SmartCycler® II) will also be discontinued on the very day. However, the last shipments of these kits will be processed throughout the summer of 2022, and we will inform customers early on when to place the final forecast and order, respectively.

 

 

Following the IVDR amendment, RealStar® products will remain available as IVDD compliant CE-IVD products. Nevertheless, RealStar® products will not be released as an IVDR compliant version, in contrast to the AltoStar® and FlexStar® counterparts, but will be eventually discontinued. Hence, the last shipments of RealStar® products will be processed in line with the end of the applicable transition periods according to the respective IVDR risk class. altona Diagnostics kindly asks for your understanding that we are not yet able to provide a more precise discontinuation date for individual RealStar® products at this point. We will keep you posted and inform you about dates ahead of time. These dates will also be posted on this web page.

 

 

Overview 2022-2027 and beyond

 

Steps to IVDR compliance

The successful transition of marketed devices to IVDR compliance requires dedicated and enduring preparation. altona Diagnostics initiated the process early to obtain AltoStar® products which will be compliant with the IVDR and cover the needs of customers who are not yet benefiting from the automated AltoStar® Workflow. These “CE: IVD 2022” products were launched in December 2021 and are available for orders.

 

However, to achieve full IVDR readiness altona Diagnostics must rely on a multiple-step model. The majority of in vitro diagnostic devices will have to be approved by the notified body under the IVDR. As soon as the notified body supervising altona Diagnostics will have been IVDR certified, the technical documentation of selected products will be reviewed before an IVDR audit can be performed. We will be allowed to get certified to declare product conformity under the IVDR. With the achievement of that milestone, altona Diagnostics will be capable to conduct the necessary activities to eventually transform the “CE: IVD 2022” devices into IVDR compliant versions. Nevertheless, customers can already benefit from our “CE: IVD 2022” products ahead of the implementation of the switch to achieve full IVDR compliance.

Frequently asked questions — IVDR and altona Diagnostics

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  • When does the IVDR come into force?

    The IVDR will gain full applicability by May 26, 2022. Devices, which belong to the IVDR risk class A, will have to be IVDR compliant by that date. IVD devices, which are categorized to future IVDR risk classes B–D, benefit from transition periods of 3 to 5 years.

  • What impact does the IVDR have on the altona Diagnostics portfolio?

    altona Diagnostics is committed to conduct the transition from IVDD to IVDR products for customers smoothly and quickly. However, the IVD regulation has certain impacts on the product portfolio:

    • Products of the (automated) AltoStar® product line were relaunched in December 2021 as “CE: IVD 2022” comprising an “open workflow” usability. This goes in line with a technical documentation that is prepared to meet the requirements of the IVD regulation. The products are aimed to be fully IVDR compliant in the second half of 2022. However, the products are already available and can be ordered.
    • Products of the upcoming FlexStar® product line will be launched as “CE: IVD 2022” including a technical documentation which prepared to meet the requirements of the IVD regulation. The products are aimed to be fully IVDR compliant in the second half of 2022.
    • Products of the RealStar® product line will eventually be discontinued. altona Diagnostics will not provide IVDR compliant RealStar® products. However, the product line benefits from the extended transition periods for IVD devices (please see next question) and the kits will still be available after May 26, 2022. Additionally, we highly encourage customers to switch to our IVDR compliant AltoStar® and/or FlexStar® product counterparts to replace the RealStar® product.
    • The AltoStar® “non-open” workflow IVDD products will be discontinued with the expiry date of January 31, 2023.

     

    For more detailed information concerning our products please contact your local altona Diagnostics sales representative.

  • How long are the transition periods?

    The IVDR transition periods for IVDD products were extended according to the IVDR risk class.

    • Future class A products will have to be IVDR compliant from May 26, 2022.
      This will affect the AltoStar® Purification Kit 1.5, the AltoStar® Whole Blood Pretreatment Buffer 1.5, the FlexStar® (RT-)PCR Amplification Mix 1.5, and the ExtraStar® Purification Kit 2.0.
    • Future class B products benefit from a transition period which allows the placing of IVDD products on the market until May 26, 2027.
      This will take effect on the products for norovirus, rotavirus, influenza A/B virus (non-pandemic), RSV, PIV, hMPV, C. difficile, and also the AltoStar® Internal Control 1.5.
    • Future class C products benefit from a transition period which allows the placing of IVDD products on the market until May 26, 2026.
      This will take effect on the products for STDs or products with the specimen type blood or CSF such as CMV, EBV, BKV, JCV, ADV, HHV 6, HSV, VZV, HAV, HEV, parvovirus B19, enterovirus, C. trachomatis, N. gonorrhoeae, Zika virus, WNV, DENV, CHIKV, Malaria, Chagas, B. pertussis, C. / M. pneumoniae.
    • Future class D products benefit from a transition period which allows the placing of IVDD products on the market until May 26, 2025.
      This will take effect on the high-risk products such as HIV, HBV, HCV, HDV, MERS CoV, SARS CoV 2, CCHFV, ebolavirus, Marburg virus, Lassa virus, yellow fever virus.
  • What are the preparations in terms of IVDR compliance at altona Diagnostics?

  • What are the differences between IVDD and IVDR?

    The in vitro diagnostic directive (IVDD) will be replaced by the in vitro diagnostic regulation (IVDR). This goes in line with the following major aspects:

    • Function (e.g., screening, monitoring, diagnosis) of the IVD will be described within the intended use
    • A new risk classification system categorizing the pathogens
    • Involvement of notified body becomes mandatory for most products
    • New clinical evidence requirements
    • Enhanced focus on post-market surveillance, vigilance, and the introduction of the EU database on medical devices (EUDAMED) to increase transparency
  • What is the impact of the IVDR on LDTs?

    Laboratory developed tests (LDTs), which are in-house developed and produced by healthcare institutions, fall under the scope of the IVDR. LDTs must fulfill the General Safety and Performance Requirements (GSPRs) of the Annex I of the IVD Regulation by May 26, 2022, and additionally, the marketing and transfer of LDTs to other legal entities will no longer be permitted. Thus, laboratories do have to demonstrate compliance with the GSPRs. Further requirements (such as QM system, EN ISO 15189 compliance (accreditation of laboratory), provision of information to the competent authority, declaration of the fulfillment of GSPRs, compiling the technical documentation) do not have to be fulfilled before May 26, 2024.


    The justification of the use of LDTs (e.g., target patient group’s specific need cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market) will be mandatory starting May 26, 2028.

     

    If an adequate product is available for the diagnosis/treatment of a (rare) disease, altona Diagnostics will highly recommend the usage of commercially available PCR assays over LDTs. That recommendation is underlined by powerful arguments providing multiple major advantages such as:

    • strict quality control of manufactured materials and products
    • intense post-market surveillance and post-market performance to identify any weaknesses and (sequence-specific) problems early on
    • reduced workload for laboratories in terms of establishing and maintaining the technical documentation

    All these aspects will gain even more focus with the applicability of the IVDR.

  • How is the classification of the risk classes under IVDR?