Are you one of those who thinks uploading instructions for use (IFU) on the website is enough to meet the requirements of electronic IFUs for European Union? Well, we don’t think so.
Wondering why?
It’s because complying to electronic IFU requirements is a lot more than uploading on the website. Before we elaborate on this, here’s a little guide to clarify some of the requirements of the EU MDR.
Is it required to upload an IFU on the website? Yes
Can e-IFU replace paper-format IFU? Yes
Are the e-IFU requirements mandatory? No
The MDR (EU) 2017/745 allows class I and class IIa devices to be exempt from having instructions for use in paper or electronic format as long as the device is proven to be safe to use without any instructions. This may mean that the risk management of a qualifying product would need to justify such an exemption. This is written in 23.1 (d) of Annex I of the regulation.
On the other hand, if the manufacturer provides instructions for use for any class of the device, they are required to upload the same information on their website, preferably on the home page to allow easy navigation for the users. This is written in 23.1 of Annex I of the regulation.
Additionally, for certain devices, instructions for use in non-paper format is also allowed as per 23.1 (f) of Annex I of the regulation. In order to conform to this requirement, the manufacturer must comply with Regulation (EU) 207/2012 – now repealed and replaced by Regulation (EU) 2021/2226.
But wait, did we just say certain devices?
Well, yes. We must also say certain types of devices. Wondering what is all this about?
Don’t worry. We prepared a Requirements Checklist for your convenience.
Keep scrolling.
This must be of help to you if you want to get rid of the tradition of giving away paper-IFU with each device.
Requirements checklist
A complete transition to electronic instructions for use, short for e-IFU, would mean an update to your quality management system as well as changes to risk management of QMS processes and relevant products. If you’re looking for help in implementing e-IFU requirements, we can help you in the following areas:
- Updating your quality management system
- Performing risk assessment for the product range
- Performing risk assessment for QMS processes
- Performing verification/validation for the e-IFU process
Alceon Medtech Consulting provides consulting services to medical device and in-vitro diagnostic device companies for regulatory compliance, quality management system related services, clinical trial management, third-party audits and wide range of trainings.
Connect with us on contact@alce onconsulting.com.
