Simplify Your Path to MDR Compliance with Professional Guidance
Overview of MDR Compliance
The Medical Device Regulation (MDR) (EU) 2017/745 ensures the safety and performance of medical devices in the EU. This regulation introduces more rigorous requirements for clinical evidence and post-market surveillance, marking a significant shift in the approval and monitoring processes for medical devices.
At GBA Group, we offer tailored services to help both new and legacy medical devices achieve MDR compliance. Our expert guidance ensures that manufacturers can meet these stringent requirements, maintain competitive advantage, and enhance market position.
Understanding MDR
MDR was introduced to improve patient safety, transparency, and regulatory consistency within the EU medical device market. Key features include:
- Improved Patient Safety: Stricter pre-market assessments and continuous post-market surveillance ensure only safe and high-performance devices reach patients.
- Increased Transparency and Traceability: The Unique Device Identification (UDI) system and EUDAMED database improve device monitoring, recall processes, and information availability.
- Modernized Regulatory Framework: Replaces previous directives to address technological advancements and unify regulatory processes across the EU.
Supporting Smaller Manufacturers
We provide strategic guidance to help smaller manufacturers navigate the heightened requirements of MDR, ensuring they remain competitive and innovative in the market.
Enhancing Patient Safety and Innovation
Our consultants ensure devices comply with regulatory requirements while aligning with high safety and quality standards, driving innovation and improving patient care.
Global Regulatory Insights
We offer a global perspective on how MDR influences international regulatory strategies and market access, helping manufacturers position themselves effectively in both EU and global markets.
Get Expert Guidance
Contact GBA Key2Compliance for expert MDR guidance. Our team will help you identify necessary adjustments, develop a tailored regulatory strategy, and support you throughout the conformity assessment process, allowing you to focus on innovation.
Visit our website to find out more about how we can assist you with MDR compliance.