Forms - templates - further documents
Medical devices
- Contents of Technical Documentation for MDD 93/42/EEC and IVDD 98/79/EC (PDF)
- Structure of Technical Documentation according to regulation 2017/745 (MDR) and MDD 93/42/EWG (PDF)
- Directory structure of technical documentation medical devices (zip, English)
- Technical documentation for reusable surgical instruments (class Ir) (PDF)
- Essential Requirements Annex I, Directive 93/42/EEC (DOC)
- List of products – medical devices 93/42/EEC (DOTX)
- Guideline for the submission of eIFU (PDF)
In Vitro Diagnostic Devices
Further documents
- List of critical suppliers / OEM-Manufacturers (DOCX)
- Notification of Changes (DOCX)
- Information electronic signature (PDF)