EU IVDR Archives - Medical Design Sourcing

Alarming results and some good news from MDR and IVDR survey of notified bodies

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By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

European IVDR application partially postponed

Ronald Boumans, Emergo by UL

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

MedTech Europe warns on ongoing regulatory issues

MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done.

The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer is seeking entry to the E.U. market. It also provides a new database to enable more transparency, a unique device identification system to assist with supply chain traceability, and stricter clinical evidence requirements. EU MDR replaces the EU Medical Device Directive (MDD), with today ending the first phase of implementation.

Get the full story on our sister site, Medical Design & Outsourcing.

EU allows remote audits for medical devices during pandemic

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively.

In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic has made in-person audits at manufacturers’ facilities difficult if not impossible.

Get the full story on our sister site, Medical Design & Outsourcing.