Greenlight Guru Presents: Under MDR- Proven Tips & Techniques

EU MDR continues to challenge not only industry, but the notified bodies responsible for certification.

Both the MDCG, and Team-NB have published guidance documents and position papers to provide insight into how to navigate these challenges, and the recent MDR transition delay has provided some alleviation IF you are eligible.

This has provided additional time to transition, but has not changed the requirements to demonstrate compliance under MDR.

Join Carolyn Guthrie, VP of Regulatory Affairs & Quality Assurance at Kapstone Medical, for an update on the latest news from the EU, including a review of regulation 2023/607, the relevant MDCG guidance documents, and comments from the European Association for Medical Devices of Notified bodies.

We will also go through techniques and tips to prepare your technical documentation per Annex II and Annex III, as well as ways to respond to your Notified Body.  We will also touch on the approach Notified Bodies are taking during review of technical documentation and the quality management system during the CE certification process under EU MDR 2017/745.