Definition: Medical Devices are instruments, apparatuses, software, or other articles intended for medical purposes, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease. Examples include surgical instruments, implants, and diagnostic equipment.
EU Regulations:
Regulation (EU) 2017/745 (Medical Devices Regulation, MDR): Governs the safety, performance, and market access of medical devices, requiring CE marking. Notified Bodies, like Xavi&Rea Solution, conduct conformity assessments (e.g., Annex IX, X, XI) to verify compliance.
Key Requirements: Risk classification (Class I, IIa, IIb, III), technical documentation, clinical evaluation, quality management system (QMS), and post-market surveillance.
Our Role: We provide conformity assessments, audits, and certification services to ensure your medical devices meet MDR standards for EU market entry.
