The BIC In Vitro Diagnostics Regulatory Roadmap is written from the manufacturer's perspective and is a map that provides guidance not only on what to do, but also on how to do it. The regulatory activities are aligned with the standards that provide the solution to achieving regulatory compliance.

The flowchart is available in a user-friendly digital format. It provides a compressed overview of the process, and at the same time it is possible to zoom in for more details.

The Roadmap includes infromation on:

  • regulatory strategy,
  • production design and planning,
  • product development,
  • development output, and
  • market and follow-up.

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.


[The content and the roadmap are provided by our partner project BIC BRIDGE. Find out more here]

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