EU MDR & IVDR Consulting

EU MDR & IVDR Consulting

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.

BioReg can help you obtain EU MDR or IVDR CE Marking for your medical device. Our services, among others, include:

  • 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 & Reports (including PDUR)
  • Writing Post Market Clinical Follow-up (PMCF) Plan & Report
  • Writing Literature Search Plan (Protocol) & Report
  • Writing Clinical Evaluation Plan & Report
  • EUDAMED Actors and Products registration
  • Building and maintenance of a Quality Management system (ISO 13485)
  • Risk assessment and management (ISO 14971:2019) Plan & Report
  • Development of Risk, Clinical Evaluation, Vigilance, and PMS procedures
  • Evaluation of significant changes
  • Devices without a medical purpose


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

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