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How European legislation affects the validation of diagnostic kits in research: the impact of the IVDR

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Regulation (EU) 2017/746 on in vitro diagnostic medical devices (known as IVDR) represents a profound change in the regulation of the diagnostic sector in Europe. Replacing the previous Directive 98/79/EC (IVDD), this regulation not only raises quality and traceability standards, but also redefines how manufacturers of diagnostic kits must design, validate and market their products.

For companies such as Immunostep, specialised in the development of flow cytometry reagents and kits applicable in both research and diagnostic contexts, the IVDR has a direct and multifactorial impact.

What is the IVDR and why is it relevant?

The IVDR entered into force in May 2017, with a transition period that has been extended for some products until 2028. It aims to strengthen safety, reliability and transparency throughout the life cycle of in vitro products. Unlike the former IVDD, the IVDR:

  • Classifies products into four risk categories (A, B, C and D) according to their clinical impact.
  • It imposes mandatory clinical, scientific and analytical validation, even for lower risk products.
  • It requires active post-marketing surveillance (PMS).
  • Introduces stricter requirements on technical documentation, traceability and assessment by Notified Bodies.

Impact of the IVDR on research and kit development

Although the IVDR is mainly oriented towards products for clinical diagnostic purposes, it has practical consequences even in the research area (RUO, Research Use Only), where many biotech companies such as Immunostep operate.

  1. Clear differentiation between RUO kits and diagnostic kits

One of the biggest challenges is to establish legal and technical boundaries between products for research use only (RUO) and those with intended diagnostic use. The IVDR requires that RUO products:

  • Are not explicitly designed for clinical results.
  • Do not include instructions for clinical use in labelling or documentation.
  • Not be promoted as a substitute for CE-IVD products.

This obliges manufacturers to review their technical documentation, labelling design, and commercial messages associated with each kit.

  1. Stricter validation for CE-IVD kits

In the event that a kit developed for research evolves into a diagnostic product, the IVDR imposes new requirements in three critical areas:

  1. a) Scientific and analytical evidence

Kits must demonstrate that they measure what they claim to measure, with validated parameters such as:

  • Analytical and clinical specificity
  • Sensitivity
  • Limit of detection (LoD) and quantification (LoQ)
  • Interlite and interlaboratory reproducibility
  1. b) Clinical evaluation

Even for known biomarkers, a specific clinical evaluation of the kit is required, based on literature or own studies.

  1. c) Quality systems

The manufacturer must work under an IVDR compliant quality management system, ideally certified under ISO 13485, and establish procedures for:

  • Change control
  • Full traceability
  • Risk management
  • After-sales surveillance (PMS and PMPF)
  1. Barriers to the marketing of new kits

The entry into force of the IVDR has reduced the number of notified bodies in Europe, causing bottlenecks in the conformity assessment process. This can delay the launch of new CE-IVD products by 12 to 24 months, affecting competitiveness and product planning.

Practical strategies to adapt to the IVDR

For companies like Immunostep, with a hybrid portfolio between research and diagnostics, adapting to the IVDR requires clear strategic decisions:

-Segmentation of the portfolio

Keep RUO and CE-IVD lines clearly differentiated, not only in labels and manuals, but also in product design, validation assays and commercial positioning.

-Modular development

Design kits from the outset with a modular architecture that facilitates future adaptation to ivdr, including internal controls, traceability and extensive validation.

-Clinical collaborations

Establish alliances with hospitals, banks or reference centres that allow access to real samples and generate quality clinical evidence.

-Investment in quality and regulation

Strengthen quality and regulatory affairs departments to ensure regulatory compliance without compromising innovation and time to market.

Conclusion: Regulation as a lever for innovation

The IVDR poses considerable challenges, especially for small and medium-sized companies, but also offers an opportunity to differentiate through quality, robustness and affordability. For Immunostep, adapting to this new framework is not only a legal obligation, but a strategic step to consolidate its position as a reliable provider of advanced diagnostic biotechnology solutions.

In a regulated environment, sustainable innovation is as much about anticipating legislation as it is about anticipating scientific needs. Because in biotechnology, quality is non-negotiable.