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!
The article is free!
Simply fill in the form below, verify your email address
and you’ll be sent a link to download the article.
Related Posts
- The European In Vitro Diagnostic Regulation: It’s Time to Start Preparing57By Erica Kramer, Ph.D., Nerac Analyst Originally Published: November 14, 2017 The global in vitro diagnostics (IVD) market was worth about $61.1 billion in 2016 and is projected to grow to $84.6 billion by 2023, with Europe accounting for the second largest market share after North America. The expected market growth, and increased interest in…
- Preparing for a Notified Body Audit56By Ron Sills, M.S., Nerac Analyst, Originally Published: October 3rd, 2014 Is your company ready for an audit by your notified body? Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that…
- Full Speed Ahead: Navigating the New European Medical Device Regulation55By Robert Zott, Director of Advisory Services Originally Published: July 18, 2018 The publication of the new Medical Device Regulation (MDR) 2017/745 in the European Journal, with its entry into force on May 25, 2017, marks the end of an eight-year period of controversy, and the beginning of a three-year transition to the most sweeping…
The post The European In Vitro Diagnostic Regulation: Performance Evaluation appeared first on Nerac.
This post first appeared on Nerac Insights And Publications - Nerac, please read the originial post: here
