EU Medical Devices Regulation (MDR 2017/745)
The European Union implemented the Medical Device Regulation (MDR 2017/745) to replace the Medical Devices Directive (MDD). The MDR became fully applicable on May 26, 2021, introducing more stringent and harmonized regulatory requirements to improve the safety, performance, and traceability of medical devices.
This shift from directives to a regulation marked a substantial change for medical device manufacturers, requiring comprehensive updates to documentation, clinical evidence, and quality systems.
Our Expertise
We specialize in helping medical device companies navigate this complex transition. Our tailored consulting services ensure your products remain compliant and your business retains uninterrupted market access under the MDR framework. We collaborate closely with your team for:
✅ Technical File Creation / Remediation
✅ PMS/PMCF Plan and Report Writing
✅ Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER)
✅ QMS Upgrade Support
✅ EU MDR Audit Readiness
AAC Edmed provided exceptional support in our recruitment process, ensuring we found the right talent for our medical device company. Highly recommend their services!
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