Hardware Podcasts

Preparing for EU MDR

Global Medical Device Podcast · 26 Nov 2019 · 30m · Episode 124

What this episode covers

Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, explains how medical device companies can prepare for the EU MDR, which was set to take effect in May 2020. She details the shift from the old Medical Device Directive (MDD) to the new regulation, emphasizing the need for comprehensive lifecycle safety data and the difficulties of establishing device equivalency. Schmitt advises companies to conduct gap analyses of their General Safety and Performance Requirements (GSPRs) and notes that many firms are using FDA pre-submission meetings to guide their EU clinical strategies.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Greenlight Guru, MD Anderson, Houston Methodist, Memorial Hermann
Also
EUDAMED, FDA

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