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EU MDR GSPR 23.1 information on website

Ellison

Starting to get Involved
#1
Good Morning,
I was wondering how everyone else is interpreting the beginning paragraph of GSPR 23.1 (See below). We had in external trainer tell us this had to be the IFU, but after some reading and discussion and are some different opinions. Could it a brochure on the website, could it be aPDF of the IFU, . A little back ground, we currently do not have eIFU’s and do not plan on going that route since we dont really meet the EU regulation requirements to have or need an eIFU. In reality the IFU would be the easiest to maintain for this but there are also addition resources to take into consideration.

Just curious what that knowleadgable minds here are thinking around this additional requirement that is kind of snuck into the GSPR..

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:


Kind Regards,
Ellison
 

MDRexpert

Involved In Discussions
#2
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:
(a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
(b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
(c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
(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.
(e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
(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
(g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer
(h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
 

François

Starting to get Involved
#3
In my understanding, you can use what ever format you want to display the requested informations as long as they are aligned with what is written on the label or IFU about the requested topics (identification, performance and safety). Indeed, I think that it will be easier to provide an electronic copy of the IFU to avoid duplication of sources.
 
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