Regulatory Open Forum

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

In making the decision, there are a few considerations. First, are you implementing a directive or a regulation? Second, if a regulation, what is your Notified Body's expectation?

For each directive, there is a list of harmonized standards (recently revised). Some Notified Bodies, incorrectly, require a manufacturer to use harmonized standards when available. Other Notified Bodies recognize that many of the harmonized standards are obsolete (and have been for years) and expected the most recent EN standard. (This leads to the next problem described below.)

For the regulations, there are no harmonized standards. There is a process call standardization (a precursor to harmonization) in which the standards bodies, CEN and CENELEC, produce the cross reference between Annex I and the standard. The Commission made a standardization request to the standards bodies, but they rejected it. At this point the process is at an impasse.

Under the regulations, you don't need harmonized standards, so, given the incorrect requirements of some NBs, this is probably a good thing.

A manufacturer needs to demonstrate that the device meets the applicable Annex I requirements. The common method uses standards. The selection decision should use the latest standard available, regardless of source, under the "state of the art principal". If there is an EN standard derived from an ISO or IEC standard, then use the EN standard. Otherwise, use the ISO or IEC standard.

Be careful with IEC 62366-1:2015. IEC just published amendment 1.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

In making the decision, there are a few considerations. First, are you implementing a directive or a regulation? Second, if a regulation, what is your Notified Body's expectation?

For each directive, there is a list of harmonized standards (recently revised). Some Notified Bodies, incorrectly, require a manufacturer to use harmonized standards when available. Other Notified Bodies recognize that many of the harmonized standards are obsolete (and have been for years) and expected the most recent EN standard. (This leads to the next problem described below.)

For the regulations, there are no harmonized standards. There is a process call standardization (a precursor to harmonization) in which the standards bodies, CEN and CENELEC, produce the cross reference between Annex I and the standard. The Commission made a standardization request to the standards bodies, but they rejected it. At this point the process is at an impasse.

Under the regulations, you don't need harmonized standards, so, given the incorrect requirements of some NBs, this is probably a good thing.

A manufacturer needs to demonstrate that the device meets the applicable Annex I requirements. The common method uses standards. The selection decision should use the latest standard available, regardless of source, under the "state of the art principal". If there is an EN standard derived from an ISO or IEC standard, then use the EN standard. Otherwise, use the ISO or IEC standard.

Be careful with IEC 62366-1:2015. IEC just published amendment 1.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.

First, it would be valuable if you told us what Green Light Guru said in the webinar.

Here is my understanding of the situation.

There is a two-step process: standardization and harmonization.

There is a regulation that governs standardization, Regulation (EU) 1025/2012.

There are standardization requests that predate the regulation. See https://ec.europa.eu/growth/single-market/european-standards/requests_en in the section Types of requests for an explanation.

The European Commission issued a standardization request to the European Standardization Organizations, ESOs, CEN and CENELEC. The ESOs refused the request. For a discussion see https://www.axonlawyers.com/standardisation-request-for-mdr-and-ivdr-refused-now-what-2/

The European Commission intends to try again in 2021. See the Draft 2021 Annual Union Work Programme at https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

It says, under Type of Action, "Revision of existing standards under new mandate (by repealing the relevant clauses of the existing mandate); Complementary work (add new work items) under new mandate".

The second step is publication in the Official Journal. This makes a standardized standard a harmonized standard.

HERESY ALERT
The intent of harmonized standards in good. By adopting one of these voluntary standards, a manufacturer obtains presumption of conformity, i.e., the device is presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. [EU-MDR Art. 8(1)]

The main problem with harmonized standards is that some Notified Bodies, NB, do not consider them voluntary. Instead they assume harmonized are mandatory and write non-conformances for failure to implement these voluntary standards.

In my opinion, device manufacturers need to strongly resist these actions. Do not accept such nonconformances and require the NB, your supplier, to correct the situation.

Manufacturers are not required to use harmonized standards; they provide a useful legal status. A device manufacturer can meet the requirements of the directives or regulations without their use.

The longer we don't have harmonized standards the better; the NBs will not be able to dream up requirements not supported by fact.

I have a couple of questions about harmonised standards and ISO standards. If the newest version has been released in the ISO website but a harmonised standard refers to an older version, which standard should the organisation needs to comply with the newest ISO or the harmonised? Should we buy both standards?

For example:
EN 62366:2008 Medical devices - Application of usability engineering to medical devices but there is the latest version of IEC 62366-1:2015 in the ISO website.

Thank you so much.