Regulatory Open Forum

Hi,

do you think that regulation 2012/207 is applicable to a ventilator that has also a built-in display? If yes, the device display has to show the instructions for use or the IFU can be provided also on an USB pen or on company's website?

I am asking this since regulation 2012/207 talks about medical devices fitted with a built-in system visually displaying the instructions for use.

How do you interpret Article 5, point 4, that states: "Manufacturers shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device"?

Do you think that it would be enough just providing information on how to start the device on the leaflet or you have to show these instructions on the device display?


------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

As explained in my prior related Forum post, first remember that, if ever IFU are provided in electronic medium for any type of medical device, then the corresponding provisions of Regulation 207/2012 ("the eIFU Regulation") must be met.  That is reiterated by EU MDR Annex I. 23.1(h).  Remember also that the fundamental intent of the eIFU Regulation is to provide certain safeguards if the IFU are provided in electronic form at all.

I would suggest that the fundamental intent of the eIFU Regulation is not to implement controls simply because a device has a built-in display.  The Regulation's recitals seem to make this clear.

Instead, for the particular context of devices that have a built-in display, the eIFU Regulation provides two general options / routes and corresponding requirements to be met if that display includes IFU.  Those two options are explained further in my prior Forum post.

Accordingly, I would interpret Article 5(4) of the eIFU Regulation as follows:  If a device is fitted with a built-in display system, and if that system displays instructions for use, then such eIFU may be provided instead of paper if the corresponding conditions of the eIFU Regulation are met.  But if the device's built-in visual display does not display the instructions for use at all (for example, if the display only contains basic operating controls without instructions for use), then Article 5(4) and any other of the eIFU Regulation's provisions for eIFU instead of paper IFU do not apply, as such a device would not be eligible for eIFU instead of paper IFU and would only be eligible for eIFU in addition to paper.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 01-Jun-2021 05:35
From: Andrea Duca
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

Hi,

do you think that regulation 2012/207 is applicable to a ventilator that has also a built-in display? If yes, the device display has to show the instructions for use or the IFU can be provided also on an USB pen or on company's website?

I am asking this since regulation 2012/207 talks about medical devices fitted with a built-in system visually displaying the instructions for use.

How do you interpret Article 5, point 4, that states: "Manufacturers shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device"?

Do you think that it would be enough just providing information on how to start the device on the leaflet or you have to show these instructions on the device display?


------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

I'll stay away from commenting on this one haha.  Save a tree, put it on screen ! :)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
------------------------------

Original Message:
Sent: 01-Jun-2021 14:25
From: Kevin Randall
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

As explained in my prior related Forum post, first remember that, if ever IFU are provided in electronic medium for any type of medical device, then the corresponding provisions of Regulation 207/2012 ("the eIFU Regulation") must be met.  That is reiterated by EU MDR Annex I. 23.1(h).  Remember also that the fundamental intent of the eIFU Regulation is to provide certain safeguards if the IFU are provided in electronic form at all.

I would suggest that the fundamental intent of the eIFU Regulation is not to implement controls simply because a device has a built-in display.  The Regulation's recitals seem to make this clear.

Instead, for the particular context of devices that have a built-in display, the eIFU Regulation provides two general options / routes and corresponding requirements to be met if that display includes IFU.  Those two options are explained further in my prior Forum post.

Accordingly, I would interpret Article 5(4) of the eIFU Regulation as follows:  If a device is fitted with a built-in display system, and if that system displays instructions for use, then such eIFU may be provided instead of paper if the corresponding conditions of the eIFU Regulation are met.  But if the device's built-in visual display does not display the instructions for use at all (for example, if the display only contains basic operating controls without instructions for use), then Article 5(4) and any other of the eIFU Regulation's provisions for eIFU instead of paper IFU do not apply, as such a device would not be eligible for eIFU instead of paper IFU and would only be eligible for eIFU in addition to paper.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 01-Jun-2021 05:35
From: Andrea Duca
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

Hi,

do you think that regulation 2012/207 is applicable to a ventilator that has also a built-in display? If yes, the device display has to show the instructions for use or the IFU can be provided also on an USB pen or on company's website?

I am asking this since regulation 2012/207 talks about medical devices fitted with a built-in system visually displaying the instructions for use.

How do you interpret Article 5, point 4, that states: "Manufacturers shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device"?

Do you think that it would be enough just providing information on how to start the device on the leaflet or you have to show these instructions on the device display?


------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

Dear Kevin,

I get your point but if the device fitted with the built-in display has to visually display the information on how to start the device, how can customers access these information if they are displayed only after the device has been started? It is a loop...

------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

Original Message:
Sent: 01-Jun-2021 14:25
From: Kevin Randall
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

As explained in my prior related Forum post, first remember that, if ever IFU are provided in electronic medium for any type of medical device, then the corresponding provisions of Regulation 207/2012 ("the eIFU Regulation") must be met.  That is reiterated by EU MDR Annex I. 23.1(h).  Remember also that the fundamental intent of the eIFU Regulation is to provide certain safeguards if the IFU are provided in electronic form at all.

I would suggest that the fundamental intent of the eIFU Regulation is not to implement controls simply because a device has a built-in display.  The Regulation's recitals seem to make this clear.

Instead, for the particular context of devices that have a built-in display, the eIFU Regulation provides two general options / routes and corresponding requirements to be met if that display includes IFU.  Those two options are explained further in my prior Forum post.

Accordingly, I would interpret Article 5(4) of the eIFU Regulation as follows:  If a device is fitted with a built-in display system, and if that system displays instructions for use, then such eIFU may be provided instead of paper if the corresponding conditions of the eIFU Regulation are met.  But if the device's built-in visual display does not display the instructions for use at all (for example, if the display only contains basic operating controls without instructions for use), then Article 5(4) and any other of the eIFU Regulation's provisions for eIFU instead of paper IFU do not apply, as such a device would not be eligible for eIFU instead of paper IFU and would only be eligible for eIFU in addition to paper.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 01-Jun-2021 05:35
From: Andrea Duca
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

Hi,

do you think that regulation 2012/207 is applicable to a ventilator that has also a built-in display? If yes, the device display has to show the instructions for use or the IFU can be provided also on an USB pen or on company's website?

I am asking this since regulation 2012/207 talks about medical devices fitted with a built-in system visually displaying the instructions for use.

How do you interpret Article 5, point 4, that states: "Manufacturers shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device"?

Do you think that it would be enough just providing information on how to start the device on the leaflet or you have to show these instructions on the device display?


------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

If a device has a built-in display that must (e.g., due to software programming) visually display start-up instructions in electronic form, then, with respect to those start-up instructions provided in electronic form (or any of the device's other instructions for use given in electronic form), then such a device would generally fall within the scope of devices defined in Article 3(1)(d) of the eIFU Regulation.  That means that, with respect to those start-up instructions provided in electronic form (or any of the device's other instructions for use given in electronic form), then the manufacturer has two options for those eIFU: 1) provide those eIFU instead of paper versions (this route is contingent on meeting the eIFU Regulation's corresponding conditions for provision of eIFU instead of paper); or 2) provide those eIFU in addition to paper versions (this route is contingent on meeting the eIFU Regulation's corresponding conditions for provision of eIFU in addition to paper IFU).

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 03-Jun-2021 05:52
From: Andrea Duca
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

Dear Kevin,

I get your point but if the device fitted with the built-in display has to visually display the information on how to start the device, how can customers access these information if they are displayed only after the device has been started? It is a loop...

------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy

Original Message:
Sent: 01-Jun-2021 14:25
From: Kevin Randall
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

As explained in my prior related Forum post, first remember that, if ever IFU are provided in electronic medium for any type of medical device, then the corresponding provisions of Regulation 207/2012 ("the eIFU Regulation") must be met.  That is reiterated by EU MDR Annex I. 23.1(h).  Remember also that the fundamental intent of the eIFU Regulation is to provide certain safeguards if the IFU are provided in electronic form at all.

I would suggest that the fundamental intent of the eIFU Regulation is not to implement controls simply because a device has a built-in display.  The Regulation's recitals seem to make this clear.

Instead, for the particular context of devices that have a built-in display, the eIFU Regulation provides two general options / routes and corresponding requirements to be met if that display includes IFU.  Those two options are explained further in my prior Forum post.

Accordingly, I would interpret Article 5(4) of the eIFU Regulation as follows:  If a device is fitted with a built-in display system, and if that system displays instructions for use, then such eIFU may be provided instead of paper if the corresponding conditions of the eIFU Regulation are met.  But if the device's built-in visual display does not display the instructions for use at all (for example, if the display only contains basic operating controls without instructions for use), then Article 5(4) and any other of the eIFU Regulation's provisions for eIFU instead of paper IFU do not apply, as such a device would not be eligible for eIFU instead of paper IFU and would only be eligible for eIFU in addition to paper.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 01-Jun-2021 05:35
From: Andrea Duca
Subject: Regulation 207 on eIFU - Applicability to ventilator with built-in display

Hi,

do you think that regulation 2012/207 is applicable to a ventilator that has also a built-in display? If yes, the device display has to show the instructions for use or the IFU can be provided also on an USB pen or on company's website?

I am asking this since regulation 2012/207 talks about medical devices fitted with a built-in system visually displaying the instructions for use.

How do you interpret Article 5, point 4, that states: "Manufacturers shall provide, on the device or on a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device"?

Do you think that it would be enough just providing information on how to start the device on the leaflet or you have to show these instructions on the device display?


------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------