Anon,
GSPR 23.1 intrinsically establishes that the information needed to identify the device and its manufacturer, and any safety and performance information relevant to the user, or any other person, can be, and often are, just a subpart of the IFU. Indeed, the IFU often contain information beyond just the device/manufacturer identification and information for safety and performance.
That said, with regard to 23.1's requirement for this information to be on your website if you have one, I too am seeing that organizations are typically just putting the whole IFU on the website. Whether the whole IFU, or the aforesaid limited subset of information, that is up to you. For example, with some devices, the information needed to identify the device and its manufacturer, and any safety and performance information relevant to the user, or any other person, are very static, and rarely, if ever, changed. In that case, having the whole IFU on the website would actually result in
more document change control burden.
Remember that the eIFU Regulation (EU) No 207/2012 was repealed (except for its use for MDD devices being placed on the market under the EU MDR's Article 120 transitional provisions). So, for devices placed on the market in regular (non-transitional) conformity with the EU MDR [Regulation (EU) 2017/745], the new eIFU regulation is Regulation (EU) 2021/2226.
But regardless of which of the eIFU regulations apply to your case, don't make the critical and costly misinterpretation that these eIFU regulations only apply when eIFU are provided in lieu of paper. Indeed, preface item (6) and Article 1 of 2021/2226 (preface item 9 and Article 1 of 207/2012) remind us that eIFU provided
in addition to paper IFU are also covered by certain provisions of these eIFU regulations, in particular as regards to the limited requirements in relation to their contents
and websites. Those website provisions appear to be quite germane to your scenario.
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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: 09-Nov-2022 09:43
From: Dan O'Leary
Subject: GSPR 23.1 interpretation
If you parse the requirement into its components they are:
The information needed to identify the device
The information needed to identify its manufacturer
Any safety and performance information relevant to the user
Any safety and performance information relevant to any other person
The problem I see is that there is safety and performance information that is relevant pre-operatively, not just post-operatively. For example, there may be information about the sterile barrier and when to open it. There may also be information about how to handle the device to prevent damage. This kind of information should be on the web site.
There are two ways to do it. One is a document that contains only the required information and the other is the IFU. I recommend using the IFU because it makes maintenance easier.
For 23.1(f), you will not trigger it, since it applies to providing the IFU in lieu of paper not in addition.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 09-Nov-2022 07:48
From: Anonymous Member
Subject: GSPR 23.1 interpretation
This message was posted by a user wishing to remain anonymous
Hello regulatory experts,
I am curious to hear how others have interpreted GSPR 23.1 in terms of what information needs to be available on the website. In a recent audit a non-conformity was raised for us regarding this requirement:
GSPR 23.1:
"Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:"
Since we manufacture implants and these are accompanied by IFU and labels with all safety and performance information we reasoned that the information on the website could be limited to safety and performance information that is relevant post operatively for example instructions for MRI since it is a titanium implant. The auditor did not agree to this interpretation and accepted that we as an immediate correction add the warnings, contra-indications, precautions and possible complications from the current IFU.
We are now in discussion if we should keep the information on the website limited to this or if we should just upload the IFU since it will be easier from a document management point of view. However, at what point do we then trigger 23.1(f)?
"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."
Is this automatically triggered if our IFU is on the website or is it only incase we would stop including IFU with the devices and rely only on the electronic IFU?
Looking forward to hear how others have solved this.
Best,
Anon