Kevin,Thank you for the insight on the eIFU regulation. To confirm, simply having a copy of the eIFU available on a website which is accessible in the EU would obligate a manufacturer to comply with relevant sections in (EU) 2021/2226, correct?I am reviewing a scenario in which an IFU with multiple translations would be added to a website for users to access. A paper copy of the IFU is already distributed with the device, so this would be an "in addition to" scenario, where (as I understand it), the "eIFU instead of paper IFU" requirements in (EU) 2021/2226 would not apply, though the likes of Article 9 would apply. But again, how I am reading this is that by simply adding that IFU to the website for users in the EU and elsewhere to download, this would obligate a manufacturer to ensure that they are compliant with the regulation.Thanks again.
Hi Thomas,Yes, I definitely consider IFU placed on a website to be eIFU.And yes, excluding Annex XVI devices, my interpretation of the aforesaid Commission stance is that any eIFU provided in addition to paper IFU must comply with the applicable provisions of Regulation (EU) 2021/2226. But this needs to be done in remembrance that only certain aspects of 2021/2226 apply to the "in addition to" scenario (I don't have those exact "in addition to" clauses off the top of my head).Best,Kevin
Related to this discussion, if I provide a PDF copy of the medical device IFU on the company website (in addition to, and identical to, the paper IFU which is packaged with the device), the PDF copy is an eIFU and must comply with 2021/2226. Since the company has a website, is it a requirement of the MDR 2017/745, Annex I, Section 23.1, to provide the PDF copy of the IFU on the company website?
Yes, article 23.1 of Reg (EU) 2017/745 requires that IFUs of medical devices are available on the company website (if such a website exists). Reg (EU) 2021/2226 describes the requirements for the provision of IFUs in electronic format (eIFU), in the case you describe the website has to meet the requirements of article 9 of Reg (EU) 2021/2226.
Uploading a PDF to a website will not qualify as an eIFU system. IFU and eIFU are integral parts of a medical device and need to be provided accordingly in a validated and quality-controlled process.
Thank you all for confirming that the PDF copy of the IFU on the manufacturer's website is indeed an eIFU which must be in compliance with applicable sections of EU 2021/2226. One of the requirements of the EU 2021/2226, Article 9, is that we must comply with Article 7, Section (2) f, which states that all previous versions of the IFU shall be available on the website. I interpret this requirement to mean that each obsolete version of the use instructions is available to the user. Am I interpreting this requirement correctly? It seems that this requirement introduces the risk of a user accessing an obsolete version of the use instructions.
I interpret it the same way and I have the same concerns. Accordingly, the previous versions need to be clearly marked and/or segregated on the website so as to maximize the users' abilities to know when they are looking at a previous version.
Only previous eIFU versions have to remain available, so if you start with eIFU now, there is no need to upload previous versions of the IFU. And yes, once there are previous versions they must be clearly marked as such and be available on your website.
"Uploading a PDF to a website will not qualify as an eIFU system."
Original Message:Sent: 15-Sep-2023 03:32From: Hans StrobelSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
------------------------------Hans Strobelwww.dokspot.ioOriginal Message:Sent: 13-Sep-2023 17:11From: Anonymous MemberSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226This message was posted by a user wishing to remain anonymous
Original Message:Sent: 24-Apr-2023 15:17From: Kevin RandallSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
------------------------------Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)Principal ConsultantRidgway, COUnited States© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.Original Message:Sent: 24-Apr-2023 14:19From: Thomas SaladinSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
------------------------------Thomas SaladinRegulatory Affairs SpecialistMinnetonka MNUnited StatesOriginal Message:Sent: 22-Mar-2022 13:59From: Kevin RandallSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226The Commission's Directorate General for Health and Food Safety told me that if ever an eIFU is provided for medical devices in the Union, whether the eIFU is provided instead of paper (for qualifying Article 3 devices) or else in addition to paper (for any devices), then the applicable provisions of Regulation (EU) 2021/2226 always apply. eIFU may not be provided outside the scope of that Regulation. Indeed, that Regulation isn't limited in scope 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 EU MDR Annex XVI devices) 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.Also, remember to integrate your compliance approach with measures to meet the EU MDR's Annex I.23.1 / IVDR's Annex I.20.1 website provision (which has overlap with the eIFU's website-related provisions).------------------------------Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)Principal ConsultantRidgway, COUnited States© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.Original Message:Sent: 22-Mar-2022 12:51From: Mauro RinaldiSubject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226Dear RAPS experts,do you have any experience providing eIFU for products outside of the listed ones in article 3 of the EU regulation 2021/2226 (repealed 207/2012)?Which is the current position of NBs?Is it possible to provide eIFUs for devices outside the scope of this Regulation?Thank you in advance for your valuable support!Mauro------------------------------Mauro------------------------------
Original Message:Sent: 9/27/2023 10:56:00 PMFrom: Anonymous MemberSubject: RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226This message was posted by a user wishing to remain anonymous
A disseminated PDF copy of the IFU is an eIFU pursuant to Regulation 2021-2226's definition.
Regarding the MDR's Annex I, Section 23.1 requirement for placement of the IFU on the manufacturer's website if the manufacturer has a website, the MDR doesn't prescribe any particular electronic format for the IFU placed on the website. However, Regulation 2021/2226 does give an important parameter for the format of the eIFU on the website. Specifically, it must be in "a commonly used format that can be read with freely available software". Accordingly, yes, PDF format is generally acceptable. But there could be other file formats that might work too as long as it meets the aforesaid formatting parameter.
while I generally agree, one small thing that is strange in Regulation 2021/2226:
Article 9 limits (as far as I can see) the availability of certain requirements for eIFU that are provided in addition to the IFU in paper form to Article 7(2), points (b)(protected against unauthorised access), (d)(fulfil the requirements of Regulation (EU) 2016/679), (e)(internet address stable and directly accessible during the archiving periods i.e. 10/15 years) and (f)(availability of previous versions).
Article 7(2)(a) that requires the eIFU to be in "a commonly used format that can be read with freely available software" is left out in this case (although it would make perfect sense to include that requirement and I would not advise to do otherwise).
Another case where I am not sure whether this is just an oversight by the regulators or has some deeper meaning.