Hardware Podcasts

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Global Medical Device Podcast · 17 Dec 2020 · 31m · Episode 172

What this episode covers

Bassil Akra, CEO and Co-Owner of QUNIQUE Group, explains the critical challenges medical device companies face in transitioning to EU MDR and IVDR, highlighting the severe bottleneck of notified body capacity and the increased burden of clinical evidence requirements. He clarifies that holding a valid MDD certificate does not buy significant time, as manufacturers must still meet MDR post-market surveillance and vigilance obligations immediately, with full certification required by mid-2023. Akra warns that the IVDR transition is particularly dangerous for the industry because 80-90% of the market will suddenly require notified body involvement, creating a resource gap that existing infrastructure cannot fill. He advises companies to read the regulations, re-evaluate notified body capacity, and manage strict implementation timelines to avoid losing market access.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
QUNIQUE Group, Greenlight Guru
Also
EUDAMED, MDSAP, ISO 14971

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