Hardware Podcasts

074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

Let's Combinate · 1 Mar 2023 · 28m

What this episode covers

Christiana Hoffman, Executive Consultant at anteris medical GmbH and former TÜV SÜD expert, explains the regulatory framework for drug-device combination products under EU MDR Article 117. She details the requirement for Notified Body Opinions for products like prefilled syringes, the distinction between GMP and ISO 13485, and the strict prohibition on consulting during the assessment process. Hoffman also outlines the timeline challenges, noting that assessments can take 75 days plus response time, and advises manufacturers to start the process 6-12 months before their EMA submission.

Most relevant to

established companies

Topics

Mentioned

Companies
anteris medical GmbH, TÜV SÜD, EMA
Also
EU MDR, Eudamed, ISO 13485, GMP

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