Forms - templates - further documents
General
- Notification of Changes (QM Standards)
- Notification of Changes - MDD/IVDD
- Notification of changes - MDR 2017/745
- Notification of changes - IVDR 2017/746
- List of critical suppliers / OEM-Manufacturers
Medical devices
- Checklist Essential Requirements for MDD 93/42/EEC
- Checklist Essential Requirements for MDR 2017/745
- Guideline for the submission of eIFU
- List of Medical Devices for MDR 2017/745
- List of products - MDD 93/42/EEC
- Structure of Technical Documentation for MDR 2017/745 and MDD 93/42/EEC
- Structure of Technical Documentation for MDR 2017/745 and MDD 93/42/EEC (Rev. 04 ZIP)
- Technical documentation for reusable surgical instruments (class Ir)
In Vitro Diagnostic Devices
- Application for lot inspection IVD
- Checklist Essential Requirements IVDD 98/79/EC
- List of products – IVDD 98/79/EC
- Checklist according to Annex I of Regulation (EU) 2017/746 (IVDR)
- List of In Vitro Diagnostic Medical Devices (IVDR)
- Structure of Technical Documentation (in vitro diagnostic devices)
- Structure of Technical Documentation (in vitro diagnostic devices) (zip)