DOWNLOADS

DOWNLOADS

everything you need to know

DOWNLOADS

We provide you with free information like templates, white-papers, guidance and posters. Have a look and get informed. We will post up-coming regulatory need-to-know information here.

MDR (EU) 2017/745

Template: Declaration of Conformity

Download of the latest Declaration of Conformity

Template: List of Applicable Standards

Download of the latest List of Applicable Standards

Template: General Safety and Performance (GSPR) Checklist

Download of the latest GSPR Checklist

Template: Checklist of Harmonized Standards

Download of the latest list of Harmonized Standards (source: EU OJ)

IVDR (EU) 2017/746

Template: Declaration of Conformity

Download of the latest 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)