Hardware Podcasts

Explaining the Role of Importer under EU MDR

Global Medical Device Podcast · 1 Jul 2021 · 34m · Episode 217

What this episode covers

René Van De Zande, partner at MedEnvoy Global and former CEO of EMERGO by UL, explains the critical role of importers under the EU Medical Device Regulation (EU MDR). He details how importers and distributors share overlapping obligations under Articles 13 and 14, requiring robust quality management systems and due diligence to ensure device compliance, traceability, and proper labeling. Van De Zande highlights the operational challenges of managing multiple distributors as de facto importers and the necessity of independent importer services to maintain supply chain control. The discussion also covers regulatory nuances in the UK post-Brexit and Switzerland following the loss of the Mutual Recognition Agreement.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
MedEnvoy Global, EMERGO by UL, Greenlight Guru
Also
EU MDR, ISO 13485, UK, Switzerland

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