BIC Regulatory Guide

Objective

The BIC Regulatory Guide was created to extend, organize, and systematize knowledge in the area of regulatory affairs related with the process of placing IVD medical devices on the European market.

The substantive value of the guide is based on new European Regulation 746/2017 (IVDR) and is intended to support stakeholders of biomarker commercialization value chain. The BIC Regulatory Guide is a comprehensive guideline reflecting the process of placing IVD products on the market in division to 7 different stages of commercialization, from discovery to commercial launch. The regulatory process is presented in the user-friendly form of regulatory tasks which are supported by additional material: links, documents and tips. The entire process is reflected by a variety of graphics with additional descriptions.

News

After a first review from project partners and implementing feedback from the Project Advisory Board, a draft version of the BIC Regulatory Guide is currently under review.

On the one hand we looking forward to the feedback from the pilot participants currently taking part in the pilot phase of the BIC MasterTool that includes regulatory aspects. On the other hand we are working with legal professionals to ensure the correctness of the BIC Regulatory Guide.

BIC Regulatory Guide
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