Regulatory Open Forum

Sven – Could you provide more information on EN ISO 14971? I have inferred that ISO 14971:2019 will be standardized as EN ISO 14971:2020. The current draft has five annex Z.

I have also expected that, at some point, there will be a harmonization process for the new regulations, and that EN ISO 14971:2020 will be a harmonized standard.

What are the current discussions?

Sven – Could you provide more information on EN ISO 14971? I have inferred that ISO 14971:2019 will be standardized as EN ISO 14971:2020. The current draft has five annex Z.

I have also expected that, at some point, there will be a harmonization process for the new regulations, and that EN ISO 14971:2020 will be a harmonized standard.

What are the current discussions?

Sven – Could you provide more information on EN ISO 14971? I have inferred that ISO 14971:2019 will be standardized as EN ISO 14971:2020. The current draft has five annex Z.

I have also expected that, at some point, there will be a harmonization process for the new regulations, and that EN ISO 14971:2020 will be a harmonized standard.

What are the current discussions?

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

Yes, there is a definition of "state of the art". I first spotted it in "ANSI/AAMI/ISO 14971:2019 Medical devices- Application of risk management to medical devices (final draft)" with a reference to its source (ISO/IEC Guide 63). It reads as follows in the AAMI document : 

3.28

state of the art

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience.

Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the "generally acknowledged state of the art".

[SOURCE: ISO/IEC Guide 63, 3.18]

There is no definition of "state of the art" found in the MDR, article 2 "definitions".
Nor do I immediately see how this furthers the discussion in this thread. Your thoughts?

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

Yes, there is a definition of "state of the art". I first spotted it in "ANSI/AAMI/ISO 14971:2019 Medical devices- Application of risk management to medical devices (final draft)" with a reference to its source (ISO/IEC Guide 63). It reads as follows in the AAMI document : 

3.28

state of the art

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience.

Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the "generally acknowledged state of the art".

[SOURCE: ISO/IEC Guide 63, 3.18]

There is no definition of "state of the art" found in the MDR, article 2 "definitions".
Nor do I immediately see how this furthers the discussion in this thread. Your thoughts?

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

Yes, there is a definition of "state of the art". I first spotted it in "ANSI/AAMI/ISO 14971:2019 Medical devices- Application of risk management to medical devices (final draft)" with a reference to its source (ISO/IEC Guide 63). It reads as follows in the AAMI document : 

3.28

state of the art

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience.

Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the "generally acknowledged state of the art".

[SOURCE: ISO/IEC Guide 63, 3.18]

There is no definition of "state of the art" found in the MDR, article 2 "definitions".
Nor do I immediately see how this furthers the discussion in this thread. Your thoughts?

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,

Yes, there is a definition of "state of the art". I first spotted it in "ANSI/AAMI/ISO 14971:2019 Medical devices- Application of risk management to medical devices (final draft)" with a reference to its source (ISO/IEC Guide 63). It reads as follows in the AAMI document : 

3.28

state of the art

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience.

Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the "generally acknowledged state of the art".

[SOURCE: ISO/IEC Guide 63, 3.18]

There is no definition of "state of the art" found in the MDR, article 2 "definitions".
Nor do I immediately see how this furthers the discussion in this thread. Your thoughts?

With kindest regards,

As I wrote in different places before : I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our industry as a whole, such as the IEC 60601-1-series, IEC 60601-2-series, IEC standards for software and for usability, and ISO standards for quality management systems, risk management, sterilization, sterile packaging, clinical investigations, and biological evaluation) becomes the European Harmonized Standard three months after its issuance as an IEC or ISO standard, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but within a practicable (doable) transition time and transition regime. 

We should also get rid of the confusion arising from an "EN" norm not necessarily being a harmonized European norm, as being harmonized requires publication in the Official Journal, and is not identifiable from the prefix of the norm.

And just for the sake of clarity : the most recent publication of norms harmonized under the MDD dates from nearly two years ago (November 2017) and it does not take a lot of pessimism to predict the number of norms that will be harmonized under the MDR by May 2020. 

Similarly, we should get rid of the notion that being "state of the art" equates "complying with a harmonized standard". 

I am glad to see that the other contributors to this thread express similar views. 

I am no legal expert, though I do have some awareness of the role and status of Harmonized Standards with the EU legal framework (e.g., Case C-613/14, James Elliot Construction Ltd v Irish Asphalt Limited and general considerations as expressed in, e.g, https://europeanlawblog.eu/2016/05/27/harmonised-european-standards-and-the-eu-court-of-justice-beware-not-to-open-pandoras-box/). So, so doing a make-over would meet with a lot of obstacles and resistance. That is not a very comforting thought for someone like me that is driven by innovation for better and safer medical devices.

With kindest regards,