Supportive Information Section mdi Europa

February 18, 2021
by mdi Europa
Composition of scientific, medical and geographic motives to illustrate an MDR/IVDR compliance process topics

Below we listed a collection of useful documents to support your compliance process. These have been compiled by or on behalf of mdi Europa and are thus not available free of charge. Please review to get a first idea of the contents and contact us, should you require the full version.

Supportive Information MDR

  1. Conformity Assessment Routes
  2. Classification Rules
  3. Declaration of Conformity Template
  4. Checklist General Safety and Performance Requirements (SPR)
  5. Checklist Technical File and Documentation
  6. Technical File and Documentation Template
  7. Labeling Requirements
  8. Clinical Evaluation Template
  9. Clinical Evaluation Checklist
  10. Checklist Post-Market Surveillance (PMS) Plan

Supportive Information IVDR

  1. Conformity Assessment Routes
  2. Classification Rules
  3. Declaration of Conformity Template
  4. Checklist General Safety and Performance Requirements (SPR)
  5. Checklist Technical File and Documentation
  6. Technical File and Documentation Template (under construction)
  7. Labeling Requirements
  8. Performance Evaluation Template
  9. Checklist Post-Market Surveillance (PMS) Plan