CE Premarket Approval

The EU Medical Device Directive (MDR) replaces the Medical Device Directive (MDD) that has been the standard for medical device regulation in the EU since 1993. If you need help to update your documentation from MDD to MDR/IVDR compliance, Sterling can help. Under the MDR, your CER and PMCF are live documents that must be routinely updated. Sterling can help update these documents as well.

Sterling can help.

Before bringing a medical device to market in the EU and other parts of the world that follow CE Mark regulation, it is essential to determine applicable regulatory requirements it must adhere to ensure patient and user safety. Sterling’s regulatory team offers services to help you identify and address key CE Mark requirements for your device including:

• CE Mark documentation support, specifically:
  • EU MDR to IVDR submission documentation gap analysis
  • Transitioning from MDD to MDR for compliance
  • EU MDR/IVDR documentation remediation
• Notified body communication support services
• Notified body audit support and remediation
• MDR clinical evaluation report support services:
  • Medical device Clinical Evaluation Report (CER) development and transition support
  • CER updates
  • EU MDR CER gap analysis
  • EU MDR CER remediation
• IVDR Performance Evaluation Report (PER) support services:
  • EU IVDR PER gap analysis
  • EU IVDR PER development and transition support
  • EU IVDR PER remediation

• PMCF (post market clinical follow-up) plan development
• PMCF updates
• Risk Management File development and updates
• Human Factors testing support