Hardware Podcasts

069 - EU MDR Extension with Michelle Lott

Let's Combinate · 25 Jan 2023 · 17m

What this episode covers

Michelle Lott, founder of leanRAQA, explains that the EU MDR extension is not a simple delay but a conditional pathway for companies that have actively transitioned their quality systems. She details two routes to extend certificates: submitting to national competent authorities or obtaining derogation from notified bodies, both requiring proof of effort and capacity constraints. Lott highlights that over 50% of technical files are rejected initially and notes that notified bodies are now selective, preferring clients who are prepared and easy to work with.

Most relevant to

established companies

Topics

Mentioned

Companies
leanRAQA
Also
EU MDR, MDCG, RAQA Today

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