Hardware Podcasts

Assessing the Global Regulatory Landscape

Global Medical Device Podcast · 21 Oct 2021 · 24m · Episode 232

What this episode covers

Adnan Ashfaq, founder of Simplimedica, discusses the rocky transition to the EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostic Regulation (IVDR) with host John Spear of Greenlight Guru. Ashfaq highlights that while MDR was delayed due to COVID-19, many companies are still ignoring the mandate, risking their business viability. He warns that IVDR poses even greater challenges due to a shortage of notified bodies and the requirement for external reference laboratories for high-risk devices.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Simplimedica, Greenlight Guru, RWS
Also
EU MDR, IVDR, EUDAMED, MDCG

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