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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
Application for lot inspection IVD
(DOC)
Contents of Technical Documentation for MDD 93/42/EEC and IVDD 98/79/EC
(PDF)
Essential Requirements Annex I, Directive 98/79/EC
(DOC)
List of products – In-vitro-Diagnostics 98/79/EC
(DOTX)
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List of critical suppliers / OEM-Manufacturers
(DOC)
Notification of Changes
(DOC)
List of withdrawn and suspended certificates
Withdrawn and suspended certificates
(PDF)
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