MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU

mf389

Starting to get Involved
I am slightly confused on when you can supply an electronic IFU instead of a paper IFU accompanying the product.

The MDR states: "(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) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section. "

in the reg 207/2021 is states:

1. Subject to the conditions set out in paragraph 2, manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices: (a) active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device; (b) implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device; (c) fixed installed medical devices covered by Directive 93/42/EEC; (d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; (e) stand-alone software covered by Directive 93/42/EEC.


Does this mean that only the devices listed above can have an e-IFU and not a paper IFU? (Unless they are class I or IIa and do not require an IFU at all)?

What If I have a Class I device (IFU not required) But I want to make an IFU available on the website (e-IFU only), but do not want to package the IFU with each device? Is this not allowed?
 
I am asking why you need an IFU at all. Who is the subset of people that you believe will seek out an electronic IFU for your low-risk device?
 

mf389

Starting to get Involved
I am asking why you need an IFU at all. Who is the subset of people that you believe will seek out an electronic IFU for your low-risk device?

It is a policy that someone was trying to implement. I understand why you are asking those questions but really I am just looking for an answer to the question "Can a class I device, that does not require an IFU, have one on the companies website, if no such IFU is supplied with the device." Don;t worry about any particulars
 
Having only an electronic IFU for a Class I device is bending rules in my opinion. However, I don't know all the details of your device.

(EU) No 207/2012 states: In order to reduce potential risks as far as possible, the appropriateness of the provision of instructions for use in electronic form should be subject to a specific risk assessment by the manufacturer.

I'm not understanding how an electronic IFU is appropriate for your device. Considering that you want to provide an IFU to some of your users, how would an electronic IFU be a better option than a paper IFU?
 

Mark Meer

Trusted Information Resource
Can your device be used safely without an IFU?

I've always been curious about what is meant by "used safely without an IFU". If the device has any precautions or warnings at all (I'm curious if any such devices exist), does this mean that it cannot be "used safely without an IFU"?

For example, a standard precaution might be: "Keep out of reach of children", or a standard warning for most active devices might be: "Do not immerse electrical components in water.", or "Do not attempt to replace, modify or repair electronic components". However, in practice (as demonstrated in usability studies and market surveillance), it may be apparent that users won't do these things, and typically use the device safely (as intended), without ever referencing the IFU.

If the inclusion of any precautions in the IFU means that eIFU is not permitted, then I suspect that 99.9% of devices will still be expected to provide paper IFUs...
 
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