Definition: As a designated Notified Body, we perform conformity assessments to certify that products meet EU regulatory standards, enabling CE marking for market access. Our focus is primarily on Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD), where Notified Body involvement is mandatory for most risk classes.
Scope and Relevance:
Medical Devices: Under Regulation (EU) 2017/745 (MDR), we conduct conformity assessments (e.g., Annex IX, X, XI) for devices in Classes I (sterile/measuring), IIa, IIb, and III, verifying safety and performance.
IVDs: Under Regulation (EU) 2017/746 (IVDR), we assess devices in Classes A (sterile), B, C, and D, ensuring compliance with performance and safety requirements.
We audit quality management systems (QMS), review technical documentation, and issue EU certificates for compliant products.
Our Role: We provide rigorous, transparent, and efficient certification services, ensuring your MDs and IVDs achieve CE marking and maintain compliance through post-market surveillance.
