Biocompatibility: Substances of Concern – Have You Checked? GSPR 10.4 a Practical Guide

Description: In the ever-evolving landscape of medical device regulations, compliance with the European Medical Device Regulation (EU MDR) is paramount for manufacturers placing their devices on the market and ensuring the safety and efficacy of those products. General safety and performance requirement (GSPR) 10.4 stands as a crucial requirement, which can be overlooked by manufacturers, resulting in potential safety issues and regulatory concerns.
This presentation will comprehensively explore this critical aspect of EU MDR compliance. It will provide a practical roadmap for manufacturers and regulatory affairs professionals to navigate the intricacies of GSPR 10.4.

Key Areas of Discussion Include: Interpreting GSPR 10.4: We break down the requirements outlined in GSPR 10.4, shedding light on its implications for medical device design, materials selection, and risk mitigation.

Substance Identification and Evaluation: We delve into strategies and best practices for identifying substances of concern within medical devices and conducting comprehensive risk assessments.

Material Selection and Compatibility: Practical insights on choosing materials that align with GSPR 10.4, ensuring they are compatible with the device's intended use.

Documentation: Guidance on preparing robust regulatory submissions that demonstrate compliance.

Join us in this informative session to understand how to navigate GSPR 10.4 effectively, ensuring that your medical devices meet the stringent safety and performance requirements of EU MDR, ultimately enhancing patient safety and market access. Take advantage of this opportunity to equip yourself with practical tools and insights for regulatory success in the European medical device market.