


Forms - templates - further documents
Further documents
- Information electronic signature
- List of critical suppliers / OEM-Manufacturers
- Guideline for digital transmission of documents
- Notification of Changes - MDD/IVDD
- Notification of changes - MDR 2017/745
- Privacy policy for IT-supported audio-/video conferences
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)