By Ronald Boumans, Emergo Group
Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions for use (IFU), technical manuals etc.) online. However clear and straightforward this may look, there are some unexpected consequences.
Get the full story here at the Emergo Group’s blog.
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