Regulatory Open Forum

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.

Hi Richard.  I always appreciate your comments.  I would suggest that you reconsider your disagreement with point 1 (the European Commission's position on the matter).  A compliance strategy based on such a position is sure to lead to compliance problems.

Remember that the EU MDR plainly states that instructions for use may be provided to the user in non-paper format (e.g. electronic), but only under the conditions set out in Regulation (EU) No 207/2012.  Remember also that Regulation 207/2012 identifies two categories of devices:  1) Those encompassed within Article 3; and 2) those not encompassed within Article 3.  Then that Regulation goes on to specify the conditions to be met whenever IFU are provided electronically.  Those conditions are generally broken down into two routes: a) provision of eIFU instead of paper (only the Article 3 devices are eligible for this route); and b) provision of eIFU in addition to paper (any device is eligible for that route).  Because of these parameters, the Commission would surely not agree that "…nowhere in 207/2012 or 2017/745 does it say eIFUs can apply to all medical devices…".  Indeed, EU MDR Annex I 23.1(h) plainly states just that.

For example, during correspondence with the Commission, I asked, "...REGULATION (EU) No 207/2012 preface item (9), and Article 1 (second paragraph), and Article 9, specify requirements to be met when medical device instructions for use are provided in electronic form in addition to paper form.  Do these Article 1 (second paragraph) and Article 9 requirements apply to all medical devices, or instead only to the particular devices listed in Article 3?..."

The Directorate General for Health and Food Safety's reply:  "...COMMISSION REGULATION (EU) No 207/2012 applies to all medical devices which have instructions for use provided electronically, regardless of whether they also provide paper format or if they benefit from...the use of electronic instead of paper format..." [emphasis added]

The EU MDR can certainly be difficult to understand at times.  Nonetheless, given the significant impact of our footprints on the businesses and communities we affect, it is crucial that we achieve accurate understanding.  Misinterpretations can do severe damage, and even put lives at risk.

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.

Hi Richard.  I always appreciate your comments.  I would suggest that you reconsider your disagreement with point 1 (the European Commission's position on the matter).  A compliance strategy based on such a position is sure to lead to compliance problems.

Remember that the EU MDR plainly states that instructions for use may be provided to the user in non-paper format (e.g. electronic), but only under the conditions set out in Regulation (EU) No 207/2012.  Remember also that Regulation 207/2012 identifies two categories of devices:  1) Those encompassed within Article 3; and 2) those not encompassed within Article 3.  Then that Regulation goes on to specify the conditions to be met whenever IFU are provided electronically.  Those conditions are generally broken down into two routes: a) provision of eIFU instead of paper (only the Article 3 devices are eligible for this route); and b) provision of eIFU in addition to paper (any device is eligible for that route).  Because of these parameters, the Commission would surely not agree that "…nowhere in 207/2012 or 2017/745 does it say eIFUs can apply to all medical devices…".  Indeed, EU MDR Annex I 23.1(h) plainly states just that.

For example, during correspondence with the Commission, I asked, "...REGULATION (EU) No 207/2012 preface item (9), and Article 1 (second paragraph), and Article 9, specify requirements to be met when medical device instructions for use are provided in electronic form in addition to paper form.  Do these Article 1 (second paragraph) and Article 9 requirements apply to all medical devices, or instead only to the particular devices listed in Article 3?..."

The Directorate General for Health and Food Safety's reply:  "...COMMISSION REGULATION (EU) No 207/2012 applies to all medical devices which have instructions for use provided electronically, regardless of whether they also provide paper format or if they benefit from...the use of electronic instead of paper format..." [emphasis added]

The EU MDR can certainly be difficult to understand at times.  Nonetheless, given the significant impact of our footprints on the businesses and communities we affect, it is crucial that we achieve accurate understanding.  Misinterpretations can do severe damage, and even put lives at risk.

1. Regulation 207/2012 applies to all medical devices.
2. Its provisions for providing eIFU instead of paper IFU only apply to certain devices, specifically those listed in Article 3 therein.  No medical devices other than those encompassed by Article 3 are allowed to have eIFU instead of paper IFU.
3. Whenever eIFU are provided in addition to paper IFU, whether that be for the Article 3 devices or for any other medical devices, then pursuant to Regulation 2017/745 (the "EU MDR") Annex 1 section 23.1, first paragraph, indent (f), then that must be done in accordance with the corresponding provisions of Regulation 207/2012.  Yet indent (f) also blankets the provision pf eIFU instead of paper IFU where such provision is allowed by Regulation 207/2012.
4. This means that for EU MDR Annex I section 23.1 first paragraph demanding that certain parts of the IFU (not the entire IFU) be placed on the website if the manufacturer has a website, then such eIFU must for any medical device be paired with paper IFU in accordance with the corresponding provisions of Regulation 207/2012 unless the device is an Article 3 device for which Regulation 207/2012's requirements have been met for providing eIFU instead of paper IFU.
5. This interpretation has been verified with the European Commission during my related correspondence with them.  Indeed, this interpretation seems to be the only logical interpretation allowed by Regulation 2017/745.  And this interpretation is maintained in the aforementioned draft regulation (with one potential exception not relevant to the current discussion).  I don't believe, and I don't think that the European Commission believes, that there is a conflict between Regulation 207/2012 and Regulation 2017/745, nor within Regulation 2017/745.  Accordingly, it's better for us to do our best at understanding these requirements in their current legislative forms, as it doesn't appear that they will be changed.