Certificado CE MDR
The European Union Medical Device Regulation (EU MDR) marks a new chapter in the regulation of medical devices within the European market.
The EU Medical Devices Regulation (EU MDR) represents a new chapter in the regulation of medical devices within the European market. This regulation, which came into effect on May 26, 2021, establishes stricter standards for the safety, efficacy, and traceability of medical devices.
Key Updates of MDR:
• More Stringent Conformity Assessment Requirements:
Medical devices must undergo rigorous testing and clinical evaluations to demonstrate their safety and efficacy before being marketed.
• Implementation of a Robust Quality Management System:
Manufacturers must implement and maintain a Quality Management System in accordance with MDR standards, ensuring quality and consistency in their processes.
• Increased Transparency and Traceability:
MDR introduces a unique device identification system (UDI) and a central European database (EUDAMED), improving product identification, traceability, and monitoring in the market.
• Extended Manufacturer Responsibility:
Companies assume greater responsibility for the safety and performance of their products, including the requirement to have a designated person responsible for regulatory compliance and the implementation of post-market surveillance measures.
Brina, our state-of-the-art family of ventilators, has recently obtained CE certification under the Medical Device Regulation (MDR). This achievement is a testament to our company’s commitment to providing safe and effective medical devices that meet the most rigorous standards. Brina ventilators provide healthcare professionals with the safety and confidence they need to deliver quality care to their patients, facilitating crucial decision-making in different situations.
With our expertise and ongoing commitment to the highest standards, we continue to advance in delivering solutions that enhance healthcare outcomes and improve the quality of life for patients worldwide.
