Regulation (EU) 2021/2226 is definitely
not limited in application only to providing electronic IFU instead of paper IFU.
Rather, along with that scenario, it also contains certain provisions applicable to
all medical devices (excluding those enfolded by EU MDR Annex XVI) whose IFU are provided in both electronic and paper format. Be sure not to err regarding that scope. This is in alignment with the longstanding precedent established by the sunsetting Regulation (EU) 207/2012.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 23-Dec-2021 11:44
From: Dan O'Leary
Subject: eIFU-(EU) 2021/2226
EU-MDR Annex I (23.1)(f) says that instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Notice that both 207/2012 and 2021/2226 cover the case IFUs in electronic form instead of in paper form.
207/2012 Article 3 has a list of devices and restrictions as does 2021/2226 Article 3. Notice however, that the lists are not the same.
2021/2226 Recital (9) resolves the issue. "In order to ensure that the rules as regards electronic instructions for use are adapted to the new requirements of Regulation (EU) 2017/745, Commission Regulation (EU) No 207/2012 should be therefore repealed. It should however continue to apply to devices placed on the market or put into service during the transitional period set out in Article 120(3) of Regulation (EU) 2017/745"
If the device is covered by MDD + MDR Article 120, then use the list in 207/2012 Article 3.
If the device is covered by full MDR, the use the list in 2017/745 Article 3.
The rules here cover electronic IFUs in lieu of paper IFUs. If the device doesn't meet the applicable Article 3, then you must provide a paper copy of the IFU.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 22-Dec-2021 17:38
From: Anonymous Member
Subject: eIFU-(EU) 2021/2226
This message was posted by a user wishing to remain anonymous
Hi Dan,
Thanks for your response, yes it further restricts the devices that can have the eIFU; so does it mean that other devices ( not in Article 3) cannot have the eIFU option or is it mandatory to accompany the device with a hard copy of the IFU additionally ?
Original Message:
Sent: 22-Dec-2021 13:03
From: Dan O'Leary
Subject: eIFU-(EU) 2021/2226
Not quite. You have cited Art 3(1) of Commission Implementing Regulation (EU) 2021/2226, so as far as you cited, it is correct. However, Art 3(2) has further restrictions that you must take into account; there may be a smaller scope of devices.
Also Art. 4 has 11 points to consider in a a documented risk assessment. It will be interesting to see how companies handle this in the EN ISO 14971:2019/A11:2021 structure.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 21-Dec-2021 22:40
From: Anonymous Member
Subject: eIFU-(EU) 2021/2226
This message was posted by a user wishing to remain anonymous
Hi ,
Needed guidance on the eIFU as per the MDR , is it correct that eIFU would be acceptable only for the following devices :
Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:
(a)implantable and active implantable medical devices and their accessories covered by Regulation (EU) 2017/745;
(b)fixed installed medical devices and their accessories covered by Regulation (EU) 2017/745;
(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.