Hardware Podcasts

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Global Medical Device Podcast · 7 May 2021 · 38m · Episode 202

What this episode covers

Joanne LeBrun, VP of Quality Systems at MDC Associates, discusses the widespread anxiety surrounding the EU In-vitro Diagnostics Regulation (IVDR) deadline in May 2022. She explains that the industry faces a critical shortage of designated notified bodies, many of which are overwhelmed or choosing not to pursue IVDR designation due to the high cost and complexity compared to the EU MDR. LeBrun advises companies to immediately apply with existing notified bodies, update their technical documentation to avoid compliance failures, and understand the distinction between ISO certification and CE marking.

Most relevant to

established companies

Topics

Mentioned

Companies
MDC Associates, Greenlight Guru, FDA
Also
IVDR, EU MDR, ISO 13485, ISO 14971, NANDO

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