All information. A single platform.

All information. A single platform.

The only platform providing all MDR & IVDR information. Accessible, comprehensive, comprehensible. 

The only platform providing all MDR & IVDR information. Accessible, comprehensive, comprehensible. 

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Up-to-date

We are the fastest in processing and communicating news on MDR & IVDR.

We are the fastest in processing and communicating news on MDR & IVDR.

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Comprehensive

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Choose from a broad range of single-purchase digital products and our membership plans.

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UDI, PRRC, PMS…ALL CLARIFIED!

UDI, PRRC, PMS…ALL CLARIFIED!

  • Covers topics of legacy devices & applicable dates
  • Obligations of economic operators & QMS
  • PRRC
  • Basic UDI-DI & UDI requirements
  • Clinical evaluation
  • Post-market surveillance obligations & needed reports
  • Grace period
  • EMDN and more!
  • Covers topics of legacy devices & applicable dates
  • Obligations of economic operators & QMS
  • PRRC
  • Basic UDI-DI & UDI requirements
  • Clinical evaluation
  • Post-market surveillance obligations & needed reports
  • Grace period
  • EMDN and more!

Purchase checklists, guidance and gap analysis documents on MDR & IVDR. Publications are produced by the experts in the sector to help you comply with the legal requirements. 

Purchase checklists, guidance and gap analysis documents on MDR & IVDR. Publications are produced by the experts in the sector to help you comply with the legal requirements. 

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MEMBERSHIP

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STORE

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Get informed on the new requirements in a more interactive way.

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WEBINARS

Follow our news section to be continuously updated with the most recent updates and news.

Follow our news section to be continuously updated with the most recent updates and news.

WE MAKE THE 

EUROPEAN MDR 

& IVDR: 

WE MAKE THE 

EUROPEAN MDR 

& IVDR: