Hello Anon,
If the main device meets the requirements under the electronic Instructions for Use (eIFU) implementing regulation, then typically any accessory as part of the "system" would also all under the scope. Now some may argue this, though if the main device has an eIFU, then could argue so does the accessories. If this decision is made, just clearly document this in the Technical Documentation with the justification and rationale. The implementing regulation does say in the pre-amble 'medical devices and accessories'. So it would just be documenting your accessory is part of the medical device which is in the scope. I will not say how the European Union eIFU process is broken and really out of date with industry - they had a great opportunity with 2021/2226 to have a good system for eIFUs in Europe and bumbled it. Yet, they still expect companies to produce paper copies of IFUs with 20+ languages. Sorry for soap box, but Europe is all "green" or so they say, but they do not follow their own rhetoric.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Aug-2022 05:29
From: Anonymous Member
Subject: electronic IFU
This message was posted by a user wishing to remain anonymous
hello,
we would like to create an electronic IFU for the accessories of our system. the system meets the following MDR requirements but, is it possible to have an electronic IFU for the accessories (sterile, single use devices)?
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 for electronic IFU:
article 3:
c) medical devices and their accessories covered by Regulation (EU) 2017/745 and fitted with a built-in system visually
displaying the instructions for use.
any suggestions for creative solutions?
thanks,