Download: aktuelle Konformitätserklärung (gem. Anhang IV der MDR (EU)
2017/745, und der IVDR (EU) 2017/746)
Download: aktuelle Liste anwendbarer Standards (MDR (EU) 2017/745)
Vorlage: Grundlegende Sicherheits- und Leistungsanforderungen (GSPR) Checkliste
Vorlage: Checklist of Harmonized Standards
Download of the latest list of Harmonized Standards (source: EU OJ)
Vorlage: Declaration of Conformity
Template: Checklist IVDR Technical Documentation (short)
Download of the latest IVDR Checklist for your Technical Documentation
Template: Checklist IVDR Technical Documentation (extensive)
Download of the latest IVDR Checklist for your Technical Documentation
Template: Checklist of Harmonized Standards
Download of the latest list of Harmonized Standards (source: EU OJ)
Template: General Safety and Performance (GSPR) Checklist
Download der aktuellen GSPR-Checkliste
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