How to comply with EU 207/2012 electronic IFU requirements for medical device apps?

Question

How should manufacturers of standalone software medical devices (apps) distributed via app stores comply with the requirements of EU regulation 207/2012 regarding electronic Instructions for Use (eIFUs), especially the requirement to provide paper versions? 
What are the expectations of Notified Bodies in such cases? Are there any practical solutions or experiences from others about providing paper IFUs for software-only apps?

Dr. Oliver Eidel · Accepted Answer

One possible solution is to embed the IFU in the app and/or provide it on your company website, with a link in the app itself. Using the eIFU symbol in the app can help. In my experience, Notified Bodies often accept this approach, especially when it's clear how users can access the IFU.

Answer

My suggestion is to state in your internal procedure that the paper IFU will be delivered upon request. In practice, this request rarely happens, so it may only be a theoretical issue.

Answer

From what I've seen (having worked as an NB auditor), you should still address the requirements of 207/2012, even if they don't make much sense for some products. Typically, companies prepare a matrix documenting the rationale for each requirement's applicability, with supporting evidence from risk management and QMS procedures. It's a regulatory requirement, so depending on your situation, you could get a minor or major nonconformity if not addressed. There's a draft of an updated eIFU regulation, but it's not published yet.

How to comply with EU 207/2012 electronic IFU requirements for medical device apps?

3 Answers

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