IN VITRO DIAGNOSTICS REGULATORY TOOLS
Technical, regulatory, and business considerations form the three corner stones of biomarker commercialization. A general understanding of regulatory issues is recommended for all stakeholders and should be taken into consideration from the very beginning of the biomarker development process.
The BIC Regulatory Tools provide a comprehensive introduction to the in-vitro diagnostics regulation (IVDR) for researchers and SMEs that are taking the first dives into this topic. The toolset consists of two separate, yet complementary tools: the IVDR Guide and the IVDR Roadmap.
The BIC In Vitro Diagnostics Regulatory Guide is written from the scientific perspective and tells what is required during the commercialization process, focusing on the so-called TTO Commercialization Model. This model forecasts close collaboration between the researcher and the technology transfer office (TTO) to achieve an efficient technology transfer to industry. TTOs serve as a catalyst for commercialization processes and assist in the comprehensive project evaluation. Proper cooperation with TTOs should lead to an investor or industrial partner engagement, or a company launch (e.g. spin-out).
The BIC In Vitro Diagnostics Regulatory Roadmap is more focused on later stages of the development and is written from the manufacturer’s perspective. The manufacturer is faced with a set of regulations and standards around the IVDs. In the IVDR Roadmap, the regulatory activities are aligned with the standards that provide the solution to achieving regulatory compliance. It is a map that provides guidance not only on what to do, but also on how to do it. 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.
IN VITRO DIAGNOSTICS REGULATORY GUIDE
Regulatory requirements play a crucial role 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.
This Guide includes information on:
- 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.
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IN VITRO DIAGNOSTICS ROADMAP
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.
