From Concepts to Validation Practice: Terminology, Parameters, and PCR Products under IVDR

The IVDR regulation (EU 2017/746) fundamentally changes the rules in the field of in vitro diagnostics. While in the past, certain aspects of method validation could be approached in a more laboratory-driven and flexible way, it is now necessary to document every step clearly and link it to regulatory requirements. At GENERI BIOTECH, we welcome this approach – although it imposes higher demands, it also supports systematic work and strengthens trust in diagnostic tools.

This article is based on a lecture we presented as part of our Science Club, a regular monthly gathering of the expert community.

At first glance, terms such as accuracy, precision, or trueness may appear self-explanatory. Practice, however, shows that different regulatory and professional frameworks assign them slightly different meanings. Whereas the ICH Q2(R2) guideline, traditionally associated with the pharmaceutical field, interprets precision primarily in a laboratory sense, the IVDR ties it directly to clinical performance and technical documentation. ISO 13485 adds its own emphases, as do metrological texts such as VIM3 or GUM. This pushes the terminology even further. For daily practice, this means one thing: terminology is not a word game. The term we choose determines what we must prove, which experiment to plan, and what documentation to produce.

The IVDR clearly defines that a manufacturer must demonstrate the analytical performance of their product. This includes a wide range of parameters that together create a complete picture of the method’s reliability. Each of these parameters must not only be measured but also justified in the context of the product’s intended use. In practice, this means validation is not just a collection of experiments, but a logically structured process that must also withstand scrutiny by a notified body.

Our internal validation frameworks are based on the structure of the Analytical Validation Protocol (AVP), Validation Experimental Protocol (VEP), and the subsequent Analytical Validation Report (AVR). Each step has its place, and none may be omitted. The rule is that the protocol must be prepared in advance – retrospective validation does not provide sufficient regulatory or professional certainty. Historical data may only be used in a supportive role, never as a substitute for prospective validation.

The validation process can be understood as a chain: from defining the purpose, setting criteria, and performing experiments, to evaluation and deviation management. IVDR further emphasizes the need for justifications of each step, as well as the assessment of inter-lot variability and the implementation of system suitability tests.

In this way, we connect legal requirements with scientific practice and create an environment in which the development, validation, and production of our products are grounded in clear data and rigorous procedures. This is an approach that not only fulfills legal obligations but, above all, provides confidence to our customers and users.

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