April 5, 2025

Notified Body certification

The Role of Notified Bodies in Medical Device Certification

Ensuring safety and efficacy is paramount for medical devices. Manufacturers aiming to market their products within the European Union must navigate a complex regulatory landscape. One of the most critical aspects of this process is obtaining CE marking—a declaration that a product complies with all relevant EU legislation. Central to this pathway is the involvement of Notified Bodies (NBs).

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