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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)

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 (DOC)

Notification of Changes (DOC)

List of withdrawn and suspended certificates

Withdrawn and suspended certificates (PDF)