Module 12 Presentations

29/01/2024

2021/2226 (link)

• (1) Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:

implantable and active implantable medical devices and their accessories covered by Regulation (EU) 2017/745; (a) fixed installed medical devices and their accessories covered by Regulation (EU) 2017/745; (b) medical devices and their accessories covered by Regulation (EU) 2017/745 and fitted with a built-in system visually displaying the instructions for use. (c)

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Clinical Data

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