207/2012 Update for MDR (?) - Instructions for Use (IFU)

D

David Hubanks

#1
We are a Class I device which will likely be Class II after MDR. We have a bluetooth sensor and associated mobile app intended for home use.

As we support many countries and interact with our patients on the app (the sensor has no display), we would like to focus most of our product help / IFU on the app itself versus a very thick multi-language printed manual since that is more reflective in the way that patients interact with the system (mobile app).

The 207/2012 regulation only allows for electronic user guides/ EIFU for cases where healthcare professionals are interacting with the product.

Looking through the MDR (Feb 2017 version) I don't see anything that would point to any obvious changes to 207/2012. Just wondering if anyone has seen anything that I may be missing or if we should just assume no changes to 207/2012.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello David and welcome to the Cove :bigwave:

This is what the MDR is saying about e-labelling:

ANNEX I

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

(...)

Chapter III
Requirements regarding the information supplied with the device

23. Label and instructions for use

23.1. General requirements regarding the information supplied by the manufacturer

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:

(...)

(f) 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.
 
D

David Hubanks

#3
Many thanks for your feedback. I suspected as much but just wanted to make sure I hadn't missed anything.

This is a great resource, I can't believe I didn't know about it before!

Cheers, David
 

Weeder

Involved In Discussions
#4
The 207/2012 regulation requires that the manufacturer conduct a risk analysis one the eIFU. I have a housekeeping question. Where should this risk analysis reside? Should it become part of the Risk Management file that we have for the product or should it be kept separate from that?

There is also process risk assessment that manufacturers perform (some time a risk register is used). What is the best way to maintain these various risk documents?
 

yodon

Staff member
Super Moderator
#5
Just my $0.02 but I would probably address it in the UFMEA.

Not sure about your question regarding the best way to maintain. They go into Doc Control like other design artifacts and must be available as part of the Risk file. Can you clarify?
 

Weeder

Involved In Discussions
#6
Just my $0.02 but I would probably address it in the UFMEA.

Not sure about your question regarding the best way to maintain. They go into Doc Control like other design artifacts and must be available as part of the Risk file. Can you clarify?
Thanks Yodon,

You are right, some clarification is needed. First, yes all the documents are in Doc control. What I mean by the best way to maintain is should I have one master risk management file that contain everything including FMEA for the product, process risk register, labeling risk assessment, supplier risk assessment, etc. (we are talking about a paper based system)? I was wondering what is the industry practice. I realize in the end it does not make much difference.
 

yodon

Staff member
Super Moderator
#7
If you mean a single, physical file, no. That, IMO, would be difficult. The standard (14971) requires a "Risk File" but that can be a virtual file; they just want all the material available. We typically do separate (physical) files for SHA, DFMEA, UFMEA, PFMEA, Risk Report, etc.
 

dgrainger

Trusted Information Resource
#8
I saw a draft implementing regulation on eIFU back in January to replace 207/2012. It added an exclusion for software devices and devices intended for lay users IF "first use typically follows a professional consultation addressing the safe and proper use of the device". I have no idea on progress nor final wording.
 
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