You are a manufacturer according to Regulation (EU) 2017/745 and have a website? Then you should take a closer look here – Annex I of the regulation provides a clear requirement for manufacturers of medical devices.
The wording of Annex I, Chapter 3, Requirement 23.1 requires, with regard to the information to be supplied with the product:
“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:”
At first glance, these are only supposedly “introductory words”, but it is worth taking a closer look here: If the manufacturer has a website, the instructions for use shall be made available there?
Subpoint f) of the MDR then becomes even more specific:
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
What does this mean for you as a manufacturer?
To this end, we take a look at the Commission’s Implementing Regulation (EU) 2021/2226, which replaced Regulation (EU) No 207/2012 in December 2021.
First of all article 3 lists up for which products it is possible at all to make the instructions for use available exclusively in electronic form. So far, this is put quite clearly and only concerns a small group of products. But we now want to look at the situation of each manufacturer, because it will be interesting if we look at Article 9 here.
This is because if the electronic instructions for use are provided in addition to the complete instructions for use in paper form, the following must be observed:
- The content of the eIfU must correspond to the content of the instructions for use in paper form
- When made available via a website, it must be protected against unauthorised access and unauthorised changes to the content. This requires a risk assessment in accordance with Article 4(1)(e).
- The website must comply with the requirements of Regulation (EU) 2016/679. This is the European General Data Protection Regulation, which is also applicable to website operators independently of the MDR.
- Manufacturers shall provide a web address that can be accessed. This shall be provided on the packaging of each unit or on the sales packaging, as appropriate. If this is not possible, it shall be supplied on paper with each device. In the case of permanently installed medical devices, this indication shall also appear on the device itself. The internet address indicated in accordance with Article 6(2) shall remain unchanged and with direct access during the periods referred to in Article 5(9) and (10).
- Those retention periods are set in line with the periods already chosen for other relevant documentation: For devices with a specific expiry date, with the exception of implantable devices, manufacturers shall keep the electronic instructions for use available to users for ten years after the last device has been placed on the market and for at least two years after the expiry date of the last device manufactured. For devices without a specific expiry date and for implantable devices, manufacturers shall keep the electronic instructions for use at the disposal of users for 15 years after the last device has been placed on the market.
- All previous versions of the instructions for use issued in electronic form must be available on the website, including the respective date of publication.
Bottom line – eIFU according to MDR and IVDR
That’s quite a lot for manufacturers of medical devices! The sentence in the (EU) MDR – if the manufacturer has a website, the instructions for use must be made available there – is not to be taken lightly. And above all, this requirement is not done by simply making the instructions for use available on the website. It takes a lot of work to establish a suitable concept for this requirement. However, this does not only affect manufacturers in Europe, but worldwide if they export to the EU. And with regard to the General Data Protection Regulation, some non-European manufacturers probably have even a bigger hurdle to overcome.
And what about the manufacturers of IVDs? The Essential Requirement is found in the same scope in Annex I, Requirement 20.1. However, the Implementing Regulation 2021/2226 only applies to medical devices according to MDR. A specific regulation for IVDs has not yet been published.
Do you have questions about the implementation of this requirement or would you like a professional exchange on this topic? Contact us, we will be happy to assist you in word and deed.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.