EU MDR CE Certification

Our service covers all CE certification activities, including:

• CE MDR Review & Gap Analysis
• MDD-MDR transition
• Initial MDR CE certification
• CE marking for Class I manufacturers
• Pre-review of Technical Files
• Writing of Clinical Evaluation, Literature, and PMS-PMCF plan & report
• CE audit management
• PRRC (Person Responsible for Regulatory Compliance) service
• Liaison with regulatory authorities (NBs, ARs, CAs)
• EU-MDR auditing & training
• Medical device classification
• Verification of applicable standards and testing requirements
• Writing MDR or IVDR Technical Documentation or review
• Review of Labeling & UDI

• Verification of compliance with General Safety and Performance Requirements (GSPR)
• Writing Post Market Surveillance (PMS) Plan & Report
• Writing Post Market Clinical Follow-up (PMCF) Plan & Report
• Writing Literature Search Plan & Report
• Writing Clinical Evaluation Plan & Report
• EUDAMED Actors and Products registration
• Building, modification, and maintenance of a quality system (ISO 13485)
• Risk assessment and management (ISO 14971:2019) Plan & Report
• Development of Clinical Evaluation, Vigilance and PMS procedures

For more information, please contact the BioReg team.