Tips and tools for dealing with the IVDR

An online seminar on the European In-Vitro Diagnostics Regulation (IVDR) took place on May 11, 2021. Almost 50 participants received an introduction to the most important points of the IVDR. There were also instructions for the Biomarker Commercialization Guide (BIC Guide) and the IVDR Regulatory Guide. With this IVDR online seminar, the two networks Interreg North-West Europe Codex4SMEs and Interreg Baltic Sea BiC offered extensive tips and tools for getting started on the current topic.

With the IVDR coming into force in about a year, manufacturers and developers of in-vitro diagnostics (IVD) and biomarkers will have to meet new legal requirements. Many companies, especially small and medium-sized companies, face major hurdles in this transition. Iweta Metzger from novineon CRO GmbH gave an insight into the most important changes. She pointed out that a new situation arises, especially for in-vitro diagnostics, which were previously not listed. Depending on which risk classification the IVD fall into according to the new regulation, the requirements for the product can be much higher than before. Anyone who needs support in this process can therefore contact Ms. Metzger.

Valérie Daussin Laurent from Aalborg University Hospital in Denmark presented the BIC Guide: a helpful online tool designed to help commercialize biomarkers. The digital handbook for researchers and SMEs guides you through the entire process from discovery to marketing of IVD-based biomarkers. It covers the clinical, regulatory and business aspects of the go-to-market process.

Last but not least, Paweł Myszczyński from Wroclaw Technology Park in Poland presented the IVDR Regulatory Guide. This guide introduces researchers and entrepreneurs to the regulatory process of CE marking for IVD diagnostics and helps plan IVDR implementation. Regulatory aspects of commercialization are explained taking into account the time and maturity aspects of the biomarker project.

The Interreg project Codex4SMEs aims to improve health care in North-West Europe and beyond through the increasing introduction of personalized medicine. A total of nine partners work together under the direction of STERN BioRegion. We will provide the B2match platform for networking free of charge until September 30, 2021. On this matchmaking platform for personalized medicine you can upload your profile in order to make new contacts with other participants.

Please find here the recording of the online seminar:

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