Hardware Podcasts

120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi

Let's Combinate · 24 Jan 2024 · 43m

What this episode covers

Monir El Azzouzi, founder of Easy Medical Device, explains the distinct roles of legal manufacturer, authorized representative, importer, and distributor under the EU Medical Device Regulation (MDR). He details how these economic operators share liability for product compliance, with authorized representatives and importers performing specific verification checks on technical documentation and labeling before products enter the market. El Azzouzi emphasizes that while distributors handle physical logistics, importers and authorized reps are responsible for regulatory clearance, including maintaining traceability through UDI and EUDAMED database registrations. The conversation highlights the critical importance of clear mandates, quality agreements, and the legal obligation for authorized representatives to terminate contracts with non-compliant manufacturers to avoid personal liability.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Easy Medical Device
Also
EU MDR, EUDAMED, ISO 13485, BfArM

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