EU MDR (2017/745)
The European Union Medical Device Regulation (EU MDR) 2017/745 governs the placement of medical devices on the European market. It replaces the former Medical Device Directive (MDD) and introduces significantly stricter requirements to enhance patient safety, product performance, and regulatory transparency.
EU MDR emphasizes comprehensive technical documentation, clinical evaluation, risk management, post-market surveillance, and traceability throughout the medical device lifecycle. Compliance with EU MDR is mandatory for manufacturers seeking CE marking and market access in the European Union.
Our EU MDR Services
- EU MDR gap analysis and transition strategy
- Medical device classification and conformity assessment
- Preparation and review of MDR-compliant Technical Files
- Clinical Evaluation Report (CER) and PMCF support
- Risk management and post-market surveillance planning
- CE marking support and Notified Body coordination
Benefits of EU MDR Compliance
- Legal access to the European medical device market
- Improved product safety and clinical evidence
- Enhanced traceability and post-market control
- Increased regulatory confidence and transparency
- Long-term compliance with evolving EU regulations
Why Choose Chitransh Groups?
Our regulatory professionals have in-depth experience with EU MDR requirements and Notified Body expectations. We provide practical, implementation-focused, and cost-effective EU MDR solutions to help manufacturers achieve CE certification efficiently while maintaining ongoing compliance.
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