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BSI First Notified Body To Officially Publish Lead Times Under EU Medtech Regulations

Predictability For Manufacturer Planning

 
• By Amanda Maxwell

BSI says it has no capacity restrictions under the Medical Device Regulation or the IVD Regulation and can start the technical documentation review for the majority of product categories within a month from submission.

Open wooden door to the new world with green environment. Climate change concept.
BSI Open Its Doors To More Transparency Over What It Can Offer • Source: Shutterstock

How large is a notified body’s capacity within the medtech field, including in specific product areas, and how long does it take a notified body to start to conduct the quality management system (QMS) and microbiology audits after the written agreement is concluded between the manufacturer and notified body?

If manufacturers had the answer to these questions, as well as how long the lead time is for technical documental assessments, it would help informed decision-making and planning.

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