Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Everyone, 

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this. 

Thanks in advance for any advice on this!

Hello

For the US consider Section 206 of the Medical Device User Fee and Modernization Act for the regulatory part. For QA, 21 CFR Part 11 and also ISO 13485 Sections 4.1.6 and 7.5.6. should be considered.

For the EU check MEDDEV 2.14/3 rev 1 from 2007. This is a guidance document. Also, consider EU Reg 2017/746 (IVDR) Chapter III, Article 20.1. For QA consider ISO 13485 Sections 4.1.6 and 7.5.6.

As there currently is no EU regulation for eIFU for IVD devices, the EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices. I would therefore recommend building your eIFU system so that it meets the requirements of this regulation. 

Best,

Hans

------------------------------
Hans Strobel
www.dokspot.io
------------------------------

Original Message:
Sent: 19-Mar-2021 10:34
From: Anonymous Member
Subject: eIFU

This message was posted by a user wishing to remain anonymous

Hello Everyone,

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this.

Thanks in advance for any advice on this!

Hi, 

Hans gave a nice overview of the regulations and guidance that directly apply to eIFU. If you are interested in some thoughts on the impact of quality system requirements and the potential applicability of EN62304 on the development of an eIFU solution, you may want to read my article at Electronic Distribution of Instructions For Use (eIFU) and Medical Device Manufacturers 

Best regards,

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
------------------------------

Original Message:
Sent: 20-Mar-2021 10:26
From: Hans Strobel
Subject: eIFU

Hello

For the US consider Section 206 of the Medical Device User Fee and Modernization Act for the regulatory part. For QA, 21 CFR Part 11 and also ISO 13485 Sections 4.1.6 and 7.5.6. should be considered.

For the EU check MEDDEV 2.14/3 rev 1 from 2007. This is a guidance document. Also, consider EU Reg 2017/746 (IVDR) Chapter III, Article 20.1. For QA consider ISO 13485 Sections 4.1.6 and 7.5.6.

As there currently is no EU regulation for eIFU for IVD devices, the EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices. I would therefore recommend building your eIFU system so that it meets the requirements of this regulation.

Best,

Hans

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 19-Mar-2021 10:34
From: Anonymous Member
Subject: eIFU

This message was posted by a user wishing to remain anonymous

Hello Everyone,

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this.

Thanks in advance for any advice on this!

Hello Hans,

Thank you for your post.  I/we appreciate the information.  Above though you state, "EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices."​  Yet do you know of any new plans to open up EU eIFU product labeling, beyond 'implantables and fixed installed medical devices'?  With EU MDR approaching, and the added IFU language requirements, some IFUs will potentially double in size.  As you know, eIFUs are searchable, with expandable text (and don't get lost, torn or smudged) - and those are just some of the clinical advantages (not to mention the multiple environmental ones).  This is why I'm hoping for more EU acceptability of eIFUs (as tends to be the case with definitely not all, but a lot of the rest of the world these days).  However, I've noticed other RAPS discussion threads where EU Class IIa devices are getting eIFUs, apparently for the EU Market.  I would not consider EU Class IIa devices to cover implantables and these don't sound like fixed installed medical devices either.  This is why I am wondering if a wider application for EU eIFUs has been accepted for some (beyond implantables and fixed installed medical devices), or maybe it is just understood (and least by some) that an EU eIFU acceptance expansion is coming soon (although -for the record- I have no proof of one)?  Thus, if you have any additional insights here, please let me know.

Thanks in advance!

------------------------------
Reuben Lidster
Regulatory Affairs Specialist
Bloomington IN
United States
------------------------------

Original Message:
Sent: 20-Mar-2021 10:26
From: Hans Strobel
Subject: eIFU

Hello

For the US consider Section 206 of the Medical Device User Fee and Modernization Act for the regulatory part. For QA, 21 CFR Part 11 and also ISO 13485 Sections 4.1.6 and 7.5.6. should be considered.

For the EU check MEDDEV 2.14/3 rev 1 from 2007. This is a guidance document. Also, consider EU Reg 2017/746 (IVDR) Chapter III, Article 20.1. For QA consider ISO 13485 Sections 4.1.6 and 7.5.6.

As there currently is no EU regulation for eIFU for IVD devices, the EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices. I would therefore recommend building your eIFU system so that it meets the requirements of this regulation.

Best,

Hans

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 19-Mar-2021 10:34
From: Anonymous Member
Subject: eIFU

This message was posted by a user wishing to remain anonymous

Hello Everyone,

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this.

Thanks in advance for any advice on this!

Hello Reuben

There is information that the EU commission will extend 207/2012/eIFU for medical APPs (including those intended to be used by laypersons) but will maintain (for the time being) the current limitations on device type (implants, implant asseccories, fixed medical devices, and medical device software).

Considering the long-lasting experience with eIFU for medical devices - the FDA regulation for eIFU is 18 years in effect, the EU regulation 9 years - as well as the position of other regulatory authorities (FDA, Health Canada, TGA, Anvisa, SFDA) it is unclear why the EU commission maintains the restrictions for the EU.

And you are right, with MDR taking effect, device manufacturers with devices used in the complete EU market will have to provide their IFUs in the 23 EU languages. With paper IFU this will lead to even more unnecessary paper, which has to be produced, transported and also discarded or recycled.

With regards,

Hans

------------------------------
Hans Strobel
www.dokspot.io
------------------------------

Original Message:
Sent: 24-Mar-2021 16:33
From: Reuben Lidster
Subject: eIFU

Hello Hans,

Thank you for your post.  I/we appreciate the information.  Above though you state, "EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices."​  Yet do you know of any new plans to open up EU eIFU product labeling, beyond 'implantables and fixed installed medical devices'?  With EU MDR approaching, and the added IFU language requirements, some IFUs will potentially double in size.  As you know, eIFUs are searchable, with expandable text (and don't get lost, torn or smudged) - and those are just some of the clinical advantages (not to mention the multiple environmental ones).  This is why I'm hoping for more EU acceptability of eIFUs (as tends to be the case with definitely not all, but a lot of the rest of the world these days).  However, I've noticed other RAPS discussion threads where EU Class IIa devices are getting eIFUs, apparently for the EU Market.  I would not consider EU Class IIa devices to cover implantables and these don't sound like fixed installed medical devices either.  This is why I am wondering if a wider application for EU eIFUs has been accepted for some (beyond implantables and fixed installed medical devices), or maybe it is just understood (and least by some) that an EU eIFU acceptance expansion is coming soon (although -for the record- I have no proof of one)?  Thus, if you have any additional insights here, please let me know.

Thanks in advance!

------------------------------
Reuben Lidster
Regulatory Affairs Specialist
Bloomington IN
United States

Original Message:
Sent: 20-Mar-2021 10:26
From: Hans Strobel
Subject: eIFU

Hello

For the US consider Section 206 of the Medical Device User Fee and Modernization Act for the regulatory part. For QA, 21 CFR Part 11 and also ISO 13485 Sections 4.1.6 and 7.5.6. should be considered.

For the EU check MEDDEV 2.14/3 rev 1 from 2007. This is a guidance document. Also, consider EU Reg 2017/746 (IVDR) Chapter III, Article 20.1. For QA consider ISO 13485 Sections 4.1.6 and 7.5.6.

As there currently is no EU regulation for eIFU for IVD devices, the EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices. I would therefore recommend building your eIFU system so that it meets the requirements of this regulation.

Best,

Hans

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 19-Mar-2021 10:34
From: Anonymous Member
Subject: eIFU

This message was posted by a user wishing to remain anonymous

Hello Everyone,

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this.

Thanks in advance for any advice on this!

Hi Reuben, 
Everybody hopes that there will be increased acceptability of eIFU for MD in Europe. However, not much seems to be moving. 
In 2019, eIFU were on the agenda of WG7 - New Technologies of the MDCG. There seemed to be the intention to consider opening up eIFU to other groups of MD. However, nothing came out of that working group thus far. Even worse, the Working Group has not planned any meeting in 2021. This means that the discussion platform is gone and to the best of my knowledge there is no other MDCG WG that picked up the issue. It does not seem to be a priority for the regulators at this moment in time. Unfortunately.
In our experience, notified bodies look carefully at eIFU implementation. Some have checklists to be used by their auditors. They look carefully both at the products covered, the eIFU solution itself and how it is controlled by the QMS. I would be surprised if NB's have made exceptions for Class IIa devices. Different interpretations between NB's can never be excluded, but it is certainly not common to deviate from the Regulation (or guidance for IVD). 
Sorry for the bad news.

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
------------------------------

Original Message:
Sent: 24-Mar-2021 16:33
From: Reuben Lidster
Subject: eIFU

Hello Hans,

Thank you for your post.  I/we appreciate the information.  Above though you state, "EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices."​  Yet do you know of any new plans to open up EU eIFU product labeling, beyond 'implantables and fixed installed medical devices'?  With EU MDR approaching, and the added IFU language requirements, some IFUs will potentially double in size.  As you know, eIFUs are searchable, with expandable text (and don't get lost, torn or smudged) - and those are just some of the clinical advantages (not to mention the multiple environmental ones).  This is why I'm hoping for more EU acceptability of eIFUs (as tends to be the case with definitely not all, but a lot of the rest of the world these days).  However, I've noticed other RAPS discussion threads where EU Class IIa devices are getting eIFUs, apparently for the EU Market.  I would not consider EU Class IIa devices to cover implantables and these don't sound like fixed installed medical devices either.  This is why I am wondering if a wider application for EU eIFUs has been accepted for some (beyond implantables and fixed installed medical devices), or maybe it is just understood (and least by some) that an EU eIFU acceptance expansion is coming soon (although -for the record- I have no proof of one)?  Thus, if you have any additional insights here, please let me know.

Thanks in advance!

------------------------------
Reuben Lidster
Regulatory Affairs Specialist
Bloomington IN
United States

Original Message:
Sent: 20-Mar-2021 10:26
From: Hans Strobel
Subject: eIFU

Hello

For the US consider Section 206 of the Medical Device User Fee and Modernization Act for the regulatory part. For QA, 21 CFR Part 11 and also ISO 13485 Sections 4.1.6 and 7.5.6. should be considered.

For the EU check MEDDEV 2.14/3 rev 1 from 2007. This is a guidance document. Also, consider EU Reg 2017/746 (IVDR) Chapter III, Article 20.1. For QA consider ISO 13485 Sections 4.1.6 and 7.5.6.

As there currently is no EU regulation for eIFU for IVD devices, the EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices. I would therefore recommend building your eIFU system so that it meets the requirements of this regulation.

Best,

Hans

------------------------------
Hans Strobel
www.dokspot.io

Original Message:
Sent: 19-Mar-2021 10:34
From: Anonymous Member
Subject: eIFU

This message was posted by a user wishing to remain anonymous

Hello Everyone,

We are currently working on providing eIFUs with our IVD kits in the US and EU, and was wanting to seek advice from the discussion forum on what guidance documents should I be referring to for this.

Thanks in advance for any advice on this!