The implementation of the European Medical Device Regulation (EU MDR) in 2021 has made the EU market more challenging for manufacturers. Global Regulatory MedDev helps companies address new requirements related to clinical evidence, labeling, quality assurance, marketing, distribution, and more. Global Regulatory MedDev also guides clients in preparing for MDR submissions.

These assessments are essential for ensuring compliance with EU MDR. Whether it’s addressing instructions for use (IFU) requirements, clinical evaluation reports (CER), or post-market surveillance (PMS) documentation, Global Regulatory MedDev consultants help build compliance plans.

To achieve MDR compliance, manufacturers must integrate EU MDR requirements into their Quality Management Systems (QMS). Global Regulatory MedDev assists in creating MDR-compliant standard operating procedures and provides templates for future submissions.

Achieving EU MDR compliance requires strategic planning and tracking of remediation efforts. Global Regulatory MedDev helps manage additional requirements across product families and technical files, ensuring a smooth execution.

Given stricter regulatory requirements, the focus on clinical data sufficiency has increased. The consulting team evaluates clinical evaluation strategies, ensuring they meet the criteria for data sufficiency.

Notified Body Response Strategy and Execution: Responding to notified bodies requires a deliberate approach based on MDR requirements. Global experts assist in closing non-conformities by writing responses and reviewing existing ones.