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The European In Vitro Diagnostic Regulation: Performance Evaluation

By Erica Kramer, Ph.D., Senior Nerac Analyst/Medical Writer
Originally Published: June 30, 2020

In May 2017, the European Parliament and Council published Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), repealing Directive 98/79/EC (IVDD). The new regulation will apply starting May 26, 2022.

Unlike under the IVDD, which allowed for self-certification for many devices and manufacturers, the IVDR will require a majority of manufacturers to obtain notified body certifications. Since there are no “grandfathering” provisions in the IVDR, this will apply even to devices that have an extensive history on the European market. The increased burden associated with the IVDR requirements, notably the increased emphasis on clinical evidence and performance, will require many manufacturers to assess their portfolio to determine which products will transition to IVDR and to prioritize technical file updates.

This article explores clinical evidence, performance evaluation and the resulting challenges to manufacturers, and offers guidance on how to navigate them with success. Read more here!

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