News

12.08.2021

Introducing the document „Summary of Safety and Clinical Performance”

The new requirements of the Medical Device Regulation (MDR) came into force on 2021-05-26 and include, among other things, a summary on the clinical safety and performance of our medical devices. The summary is provided in the document "Summary of Safety and Clinical Performance", SSCP for short, and is available for download in all EU languages for the products Ceramill A-Temp / Ceramill A-Temp Multilayer and Zolid Gen-X on the Amann Girrbach website: https://www.amanngirrbach.com/en/services/downloads/additional-documents/

A further requirement of the MDR is that new language versions must be created for all Instructions for Use. In future, you will find the following additional language versions of Instructions for Use for medical devices on our website:
• Bulgarian
• Finnish
• Estonian
• Croatian
• Slovak
• Slovenian

The language versions of the Instructions for Use can be found on our global English corporate website under https://www.amanngirrbach.com/index.php?id=127&L=0.

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