Changes to the provision of electronic instructions for use for medical devices

For medical devices, it is possible to provide instructions for use in electronic form. However, this was previously limited to certain products by Regulation (EU) 207/2012. New regulations under Regulation (EU) 2017/745 With the current Medical Devices Regulation (EU) 2017/745, this option has been retained in Annex I, Chapter III. More precise regulation was provided by the Implementing Regulation (EU) [...]

Standards relevant to technical documentation – July 2025

Withdrawal announced: VDI 4500 Sheet 6 on technical documentation In June 2025, it was officially announced that Part 6 of VDI Guideline 4500 ("Technical Documentation - Documentation Process - Publishing") is to be withdrawn. The guideline is considered technically outdated and no longer meets the current requirements for modern documentation processes. However, the withdrawal [...]

2026-03-25T12:42:55+02:0001.07.2025|Kategorien: Normen und Richtlinien|Tags: , , |0 Kommentare
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