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?
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?