Hardware Podcasts

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Global Medical Device Podcast · 22 Apr 2020 · 30m · Episode 143

What this episode covers

Jon Speer hosts a live discussion with Evangeline Loh, Vice President of Regulatory Affairs at Emergo Group, regarding the impact of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) on the medical device ecosystem. They detail critical regulatory shifts, including the delay of the EUDAMED database to 2022, the up-classification of self-certified Class I devices under Corrigendum 2, and the severe bottleneck caused by having only 11 designated Notified Bodies. The conversation highlights the strategic advantage of securing legacy MDD certification before May 2020 to avoid MDR compliance until 2024, while also addressing the regulatory duplication and market access challenges introduced by Brexit.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Emergo Group, BSI
Also
EUDAMED, MHRA, NANDO, IVDR, ISO 13485

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