during MDR technical file assessment we got a question from our notified body regarding Regulation 2021/2226 and how we meet its requirements. We manufacture single-use medical devices risk class IIa and we supply each packaging with a printed paper IFU - therefore we assumed the Regulation on e-IFU does not apply. We answered the question in this contect, however the answer was rejected with following explanation: the Regulation is also applicable to electronic IFUs which are provided in addition to the paper form (see article 9). Can anyone help with explanation of the term "in addition" in this meaning? We do not make our IFUs available online to substitute the paper version.
The only reason that I can think of is the MDR requirement on necessary information provided on our webiste (MDR - Annex I, 23.1, first paragraph). To meet this requirement we uploaded our English master IFU to the website (properly secured, with red watermarks and warning that the user shall always follow the country-specific revision of IFU supplied with the device) to avoid any misuse or misinterpretation. From our point of view this IFU is not provided in addition to the paper form. Or are we wrong? May we handle this issue by removing the IFU from the website and replace that by a text copied from the IFU directly to the website (to meet the MDR requirement 23.1)?
Does anyone has similar experience? What measures did you take? Do you have any other ideas how to answer the question?
Thank you very much!
if you search in the forum you will probably find several threads on this topic, and as far as I remember the conclusion usually was: Making the instructions for use available on the website to fulfill the respective Annex I requirements usually is considered to lead to the applicability of Regulation (EU) 2021/2226 within the limits mentioned in Article 9 for information provided additionally in electronic form.
This would mean you need to do a risk-based approach to protection from tampering, comply with the GDPR requirements (which you need to do anyway), ensure the availability of the internet adress for the respective retention times and make available previous versions of the electroncially provided IFR (not a complete history of your paper IFUs).
Given that the definition of instructions for use in Article 2 (14) generally refers to information that is provided without prescribing a format I doubt that you can waive this by placing the information directly on the web page instead of linking the pdf document.
Best regards, Christoph
True. It seems the only way to avoid that regulation is not to have a website at all.
My experience and understanding is that when the IFU (whether in full or in part) are put onto the website (whether in response to the Annex I.23.1 first paragraph website provision, or for another reason), then those website instructions for use (whether in full or in part) are considered to be non-paper format (e.g., electronic) and thus subject to the applicable provisions of Regulation 2021/2226 pursuant to Annex I.23.1(f). I say "whether in full or in part" because "any safety and performance information relevant to the user, or any other person" required by Annex I.23.1 first paragraph to be on the website (if the manufacturer has a website) is only part of the fuller IFU content required by section 23.4. Ultimately, the website IFU (a type of eIFU) or any other type of eIFU will always either be a) electronic format instead of paper format, or b) electronic format in addition to paper format. Because of Annex I.23.1 first paragraph's website provision, it essentially forces the manufacturer to have some degree of eIFU unless the manufacturer has no website.
Sorry you are having difficulty with this - there is so many interpretations and poorly written regulation to start - when thinking of this subject the image of clowns driving around in little cars always pops into my head for EU/Notified Bodies. There are some which say you must have an eIFU so having a paper format and then having on the company website (reference the 'and shall' below). There are others which say if your device does not meet the 2021/2226 Regulation than you can absolutely not have an eIFU. Then others which if you have any product information on the company website views this as eIFU information. Shakes head.
First, get absolute clarification on the expectation from your Notified Body - because at this time it is "a requirement" without having better wording in the Regulation or a guidance document providing clear direction. Without maybe having that, clearly define within your own quality system and Technical Documentation what you do or do not for electronic Instructions for Use (eIFU). This is including information which you may already have on the company website. If the product is already provided with a paper IFU, and the organisation is not going to do an eIFU (because it is a single-use device), document rationale and reasons in your technical documentation for the approach. (Edit: And yes, maintaining an eIFU on a company website can be a lot of additional work for a small company.) It is amazing two words 'and shall' create so many obstacles for companies. Tell the auditor your company website is not an appropriate platform for instructions for use because it is only a social media platform :).
------------------------------Richard Vincins ASQ-CQA, MTOPRA, RACVice President Global Regulatory Affairs------------------------------
------------------------------Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)Principal ConsultantRidgway, COUnited States© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.Original Message:Sent: 16-Nov-2023 10:56From: Christoph KiesselbachSubject: Printed paper IFU and Regulation 2021/2226 (rules for electronic IFU of medical devices)
------------------------------Christoph KiesselbachReutlingenGermanyOriginal Message:Sent: 16-Nov-2023 03:27From: Anonymous MemberSubject: Printed paper IFU and Regulation 2021/2226 (rules for electronic IFU of medical devices)This message was posted by a user wishing to remain anonymous
First a disclaimer: I am working for a company that provides and maintains the IT infrastructure for eIFU Systems of medical and in-vitro diagnostic device companies. I leave it to you to judge the objectivity of my advice but I have been involved in numerous eIFU System reviews by notified bodies and other authorities - both for replacing the paper IFU and for providing eIFU in addition to paper IFU - and I think that your notified body has a relevant point in asking the question.
Device manufacturers often have the notion that eIFU means uploading an electronic IFU somewhere on a website with the hope that somebody finds it and then hopefully selects the right document. Too many hopes. Such a process can not pass a risk assessment simply because there is no control over what document the device user selects. If you compare such a scenario with the processes and controls you have in place to ensure that the right paper IFU is assembled with the device, then this can hardly be seen as an improvement for the safe use of the device.
What your auditor is looking for are eIFU QA processes:
Setting up these processes is not complex but very helpful in determining, understanding, and demonstrating the criticality of eIFU for product compliance. Hope this makes sense and is helpful, kind regards,
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