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Why Virtual Manufacturing Is Likely To Be Less Popular Under EU’s New Device Regulations

 
• By Amanda Maxwell

The scale of responsibilities for a virtual manufacturer under the EU’s new Medical Device and IVD Regulations may deter many companies from taking on this role. Elisabethann Wright, partner at Cooley law firm, explains why.

Robotic arms like the one pictured may be promoted through an FDA-NIST agreement to advance medtech manufacturing.

It is not necessary to physically produce a device to be a manufacturer. A company can source products from other manufacturers (often referred to as original equipment manufacturers ̶ OEMs) and thereby become a “virtual manufacturer”.

But in so doing, and in putting its own name on the product, the virtual manufacturer accepts legal responsibility for the device and is regarded as “the manufacturer.”

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