Interreg Baltic Sea Region - European Regional Development Fund
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In Vitro Diagnostics Regulatory Guide

Crucial role of regulatory requirements in IVD biomarker assay development.

The BIC In Vitro Diagnostics Regulatory Guide introduces researchers and entrepreneurs to basic understanding of the regulatory process for CE mark of IVD diagnostics, along with the development of the project toward a clinical product.

The “Overview of regulatory and authorisation challenges and transnational exchanges of clinical data and samples” was created to extend, organise, and systematise expertise of regulatory affairs concerning stakeholders in the value chain of biomarker commercialization, who participate in the process of introducing in vitro diagnostic (IVD) biomarker products to the market.

This Guide is the source of information regarding:

  • how to approach regulatory affairs,
  • planning of IVDR implementation,
  • management of regulatory aspects of commercialization,
  • positioning the regulatory obligations within relevant commercialization stages, taking into account aspects of time and maturity of the biomarker project,
  • introducing good practices related to regulatory field.

NOTICE: With the introduction of new European regulations (from IVD medical device directive to IVD medical device regulation), there is some regulatory uncertainty and currently no interpretation available. It is therefore essential to study the original legal texts; it is often advisable to consult the competent authorities. In order to gain the most comprehensive knowledge, this document should be read in conjunction with other tools developed by the BIC project and additionally with IVDR.