CE MDR – Clinical Investigation Requirements
Under the European Medical Device Regulation (EU MDR 2017/745), clinical investigations are critical for demonstrating the safety and performance of medical devices before they can receive CE marking. These requirements ensure that devices meet stringent health, safety, and performance criteria.
The process involves:
✅ Preparing a Clinical Investigation Plan (CIP)
✅ Obtaining Ethical Committee Approval
✅ Notifying the Relevant Competent Authority
✅ Maintaining comprehensive documentation, including informed consent, risk-benefit analysis, and post-market clinical follow-up (PMCF), to support conformity assessment and ongoing compliance under the MDR framework.
Our Services
🔹 Device Classification & Approvals
🔹 Providing Risk Analysis for Medical Devices (ISO 14971:2019)
🔹 Clinical Investigation Plan (CIP)
🔹 Instructions for Use (IFU) + Label
🔹 Clinical Evaluation Report (CER)
🔹 Monitoring Product Safety
🔹 Application Submission
