Hardware Podcasts

051 - "EU MDR" with Bassil Akra

Let's Combinate · 21 Sept 2022 · 44m

What this episode covers

Bassil Akra, CEO of AKRA Team and former VP at TÜV SÜD, explains the implementation challenges of the EU Medical Device Regulation (MDR) 2017/745, focusing on the critical shortage of designated Notified Bodies and the resulting capacity constraints for manufacturers. He details the regulatory distinctions between Notified Bodies and Competent Authorities, clarifying that while Notified Bodies perform conformity assessments, Competent Authorities handle market surveillance and designate the bodies themselves. Akra specifically addresses Article 117 for drug-device combination products, explaining how manufacturers must obtain a Notified Body opinion on the device component if it lacks a CE mark, rather than a full certification, to support the medicinal product's market authorization.

Most relevant to

established companies

Topics

Mentioned

Companies
AKRA Team, TÜV SÜD
Also
EU MDR, IVDR, Article 117, EMA

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