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.

Read more
  • 0

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.

Read more
  • 0

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.

Read more
  • 0