Key Aspects of the MDR We Help You Navigate:

• Device Classification & Conformity Assessment: Under the MDR, devices are classified into four risk categories (Class I, IIa, IIb, and III). We assist you in determining the correct classification for your medical device and help you choose the appropriate conformity assessment route, including working with Notified Bodies for higher-risk devices.
• Clinical Evidence & Evaluation: The MDR mandates comprehensive clinical evaluation for medical devices to demonstrate safety and effectiveness. Our team supports you in conducting clinical trials, preparing clinical evaluation reports (CER), and ensuring your product meets the clinical data requirements necessary for regulatory submission.
• Post-Market Surveillance (PMS): The MDR places significant emphasis on post-market surveillance to monitor the safety and performance of medical devices once they are on the market. We help you establish effective PMS systems, including adverse event reporting, vigilance systems, and periodic safety update reports (PSURs) to ensure ongoing compliance and patient safety.
• Unique Device Identification (UDI): The MDR introduces the requirement for Unique Device Identification (UDI) for traceability purposes. We guide you through the process of implementing a UDI system, ensuring compliance with both the MDR and global traceability standards.
• Technical Documentation & Files: We assist in creating and maintaining the necessary technical documentation and device dossiers required for MDR compliance. Our team ensures that all documentation is complete, accurate, and up-to-date, covering design, manufacturing processes, risk management, and clinical data.
• Notified Body Engagement: For higher-risk devices, engagement with a Notified Body is required under the MDR. We help you prepare for and manage the Notified Body review process, ensuring smooth audits and successful certification.
• Labeling & Instructions for Use (IFU): The MDR has specific requirements for labeling and instructions for use, including mandatory warnings, symbols, and information regarding the device’s intended use. We help ensure that your product labeling complies with MDR requirements and meets the needs of healthcare professionals and patients.
• Vigilance & Reporting Obligations: The MDR requires manufacturers to actively monitor and report on the safety of their devices through vigilance systems. We support the establishment of robust vigilance processes, ensuring timely reporting of serious incidents, field safety corrective actions (FSCA), and corrective and preventive actions (CAPA).
• Human Factors & Usability Engineering: The MDR highlights the importance of usability in ensuring that medical devices are safe and effective for users. We assist with usability studies, risk assessments, and human factors engineering to minimize user-related risks.
• Transitional Provisions & Legacy Devices: If your device was previously certified under the MDD, we provide guidance on how to transition to the MDR requirements. This includes ensuring that legacy devices are updated to meet the new regulatory standards and helping with any necessary re-certification.

Why Choose Us for MDR Compliance?

• Expert Guidance: Our team of experienced regulatory professionals has a deep understanding of the MDR and the nuances of medical device regulations across the EU.
• End-to-End Support: From initial planning and classification to post-market surveillance, we offer end-to-end support, ensuring your devices are always in compliance with the latest regulatory requirements.
• Efficient Market Access: We help accelerate your time to market by ensuring all aspects of MDR compliance are covered, enabling a smooth regulatory submission process.
• Risk Mitigation: Our comprehensive approach helps you identify and mitigate risks early, ensuring that your devices meet the highest standards of safety and effectiveness throughout their lifecycle.

Let us simplify your MDR compliance journey, helping you bring safe, effective, and compliant medical devices to market with confidence. With our regulatory expertise, we ensure that your product meets all necessary requirements, giving you peace of mind in an increasingly complex regulatory environment.