Hardware Podcasts

Challenges for Regulatory Submission: EU vs. US

Global Medical Device Podcast · 6 May 2022 · 40m · Episode 259

What this episode covers

Michelle Lott, Founder of leanRAQA and former FDA DGMPAC member, explains the severe regulatory hurdles of the EU MDR compared to the US FDA pathway, noting that 18,000 MDD certificates were issued but only 1% have transitioned to MDR. She highlights that companies face exorbitant notified body fees, a bottleneck of only 28 notified bodies, and the requirement for ISO 13485 certification, leading many small and large firms to withdraw from the EU market. Lott advises startups to perform a market analysis to determine if their revenue model supports these recurring costs, warning that 'hope is not a regulatory strategy' as certificates expire in May 2024. The discussion covers the shift from a linear US submission process to a continuous, living system in the EU, including annual audits and recertification every three years.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Green Light Guru, leanRAQA, Nestle
Also
FDA, EU MDR, ISO 13485

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