EU MDR & EU IVDR CE Certification

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

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.


In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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