Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All, 

I have a couple of questions regarding the Essential Principles Checklist for IVD devices. 

1. If a product was designed and tested years back and previous Standards that have now been revised/withdrawn were used, is it okay to list the withdrawn or outdated Standard as the method of conformity? Due to the fact that the withdrawn standard was technically used at the time of development? Or should the Essential Principles Checklist only list current Standards?

2.  If a Standard is used on the Essential Principles Checklist should it also be listed on the Declaration of Conformity? In other words, should those two documents match standard for standard?  A Standard might be used as a guiding document on the Essential Principles Checklist, but not necessarily 100% conformed to for the DoC.

Thanks for you help

Hello Anon,

Just as a note, the Essential Principles for IVD devices you might be referring to Australia or GHTF, this is known as General Safety and Performance Requirements (GSPR) in Europe.  Also the term checklist is used, but we know the information contained in a Essential Principles (EP), Essential Requirements (ER), or GSPR, whichever terminology is used, is more than a checklist - more of a matrix for how information supports the safety and performance of a medical device.  To answer your questions, you will find there are quite a variety of positions on this because the use of standards and the version used is often a contentious topic between the company and regulatory reviewer and even within the industry.  Unfortunately there is not a guide or clear statement out there on exactly what is acceptable except phrases like "state of the art" or Good Manufacturing Practice (GMP).  Although you do have some better definitive areas like the US FDA who have their recognised standards database or even guidance in Europe now.

1. My opinion is the EP/ER/GSPR should only list current standards, because of a reason stated above like state of the art.  However, you can still list conformance to previous standards, such as when the actual testing was performed which some companies do. Though with any progression of standards and their usage is the expectation following the current standard, i.e. state of the art or GMP.  What this means is while you can cite conformance to a previous version, internally there should be documentation supporting why this is still acceptable, and why testing has not been performed to the current version.  This is an impact assessment, gap analysis, and type of justification document.  An often used example is ISO 10993-1 where a device developed back in 2007 may have been tested to the version then but the "current" version is 2020.  It does not necessarily mean the device is tested again to current version, but an assessment is performed to determine if additional testing may be required.  In many cases there is a substantial amount of documentation generated.  Again, there are many different views on this and it can be quite involved, this is just a brief thought from myself.
2. For the Declaration of Conformity (DofC), it is commonly understand the "main" product specific standards are listed in the DofC, i.e. IEC 60601-1, ISO 11135, ISO 10993-5/-10, and other product specific testing standards like ISO 80601-2-56 for say thermometers.  As an example, I do not put standards like ISO 13485, ISO 14971, or even like IEC 62304 because these are "quality system" standards which as a medical device company would be expected to comply.  While these standards would be listed in the EP/ER/GSPR matrix, I would not necessarily include them on the DofC.  Again, the view of this can vary so there are different ways this can be done by companies.  In addition, the regulatory authority (Notified Body or Approving Body) may want specific information listed on the DofC as well, including all the standards which may be listed in the matrix.  I have seen this before so the DofC contains an "Appendix" with a complete list of all the standards which are applied for conformity.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 17-Nov-2022 09:07
From: Anonymous Member
Subject: Essential Principles Checklist Questions

This message was posted by a user wishing to remain anonymous

Hello All,

I have a couple of questions regarding the Essential Principles Checklist for IVD devices.

1. If a product was designed and tested years back and previous Standards that have now been revised/withdrawn were used, is it okay to list the withdrawn or outdated Standard as the method of conformity? Due to the fact that the withdrawn standard was technically used at the time of development? Or should the Essential Principles Checklist only list current Standards?

2.  If a Standard is used on the Essential Principles Checklist should it also be listed on the Declaration of Conformity? In other words, should those two documents match standard for standard?  A Standard might be used as a guiding document on the Essential Principles Checklist, but not necessarily 100% conformed to for the DoC.

Thanks for you help

Just to add one little bit to Richard's pretty comprehensive reply.

Do not assume that conformity to a standard is sufficient.

Why do I say that? It depends on the standard and its contents, as well as where that standard sits within the generally acknowledged state of the art. Even the latest version of a fundamental product standard could be a few years behind emerging issues that users, regulators and industry are seeing within the post market surveillance data. As Richard says, the EP/ER/GSPRs are not there for a checklist but are there to drive consideration of known safety and performance issues and are equivalent to the hazard identification process laid out in clause 5 of ISO 14971. The guidance for that standard is given in ISO TR 24971, and Annex E of that guidance provides considerations for how to use standards within the risk management process. The key line from that Annex that I want to highlight is "... can be considered acceptable unless there is objective evidence to the contrary (for example reports of adverse events, product recalls or complaints)". That 'evidence to the contrary' will likely come from your post market surveillance and monitoring of the inputs for what is considered the generally acknowledged state of the art for your device.

------------------------------
Edward Ball
Manager, Intelligence & Innovation
United Kingdom
------------------------------

Original Message:
Sent: 18-Nov-2022 02:53
From: Richard Vincins
Subject: Essential Principles Checklist Questions

Hello Anon,

Just as a note, the Essential Principles for IVD devices you might be referring to Australia or GHTF, this is known as General Safety and Performance Requirements (GSPR) in Europe.  Also the term checklist is used, but we know the information contained in a Essential Principles (EP), Essential Requirements (ER), or GSPR, whichever terminology is used, is more than a checklist - more of a matrix for how information supports the safety and performance of a medical device.  To answer your questions, you will find there are quite a variety of positions on this because the use of standards and the version used is often a contentious topic between the company and regulatory reviewer and even within the industry.  Unfortunately there is not a guide or clear statement out there on exactly what is acceptable except phrases like "state of the art" or Good Manufacturing Practice (GMP).  Although you do have some better definitive areas like the US FDA who have their recognised standards database or even guidance in Europe now.

1. My opinion is the EP/ER/GSPR should only list current standards, because of a reason stated above like state of the art.  However, you can still list conformance to previous standards, such as when the actual testing was performed which some companies do. Though with any progression of standards and their usage is the expectation following the current standard, i.e. state of the art or GMP.  What this means is while you can cite conformance to a previous version, internally there should be documentation supporting why this is still acceptable, and why testing has not been performed to the current version.  This is an impact assessment, gap analysis, and type of justification document.  An often used example is ISO 10993-1 where a device developed back in 2007 may have been tested to the version then but the "current" version is 2020.  It does not necessarily mean the device is tested again to current version, but an assessment is performed to determine if additional testing may be required.  In many cases there is a substantial amount of documentation generated.  Again, there are many different views on this and it can be quite involved, this is just a brief thought from myself.
2. For the Declaration of Conformity (DofC), it is commonly understand the "main" product specific standards are listed in the DofC, i.e. IEC 60601-1, ISO 11135, ISO 10993-5/-10, and other product specific testing standards like ISO 80601-2-56 for say thermometers.  As an example, I do not put standards like ISO 13485, ISO 14971, or even like IEC 62304 because these are "quality system" standards which as a medical device company would be expected to comply.  While these standards would be listed in the EP/ER/GSPR matrix, I would not necessarily include them on the DofC.  Again, the view of this can vary so there are different ways this can be done by companies.  In addition, the regulatory authority (Notified Body or Approving Body) may want specific information listed on the DofC as well, including all the standards which may be listed in the matrix.  I have seen this before so the DofC contains an "Appendix" with a complete list of all the standards which are applied for conformity.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 17-Nov-2022 09:07
From: Anonymous Member
Subject: Essential Principles Checklist Questions

This message was posted by a user wishing to remain anonymous

Hello All,

I have a couple of questions regarding the Essential Principles Checklist for IVD devices.

1. If a product was designed and tested years back and previous Standards that have now been revised/withdrawn were used, is it okay to list the withdrawn or outdated Standard as the method of conformity? Due to the fact that the withdrawn standard was technically used at the time of development? Or should the Essential Principles Checklist only list current Standards?

2.  If a Standard is used on the Essential Principles Checklist should it also be listed on the Declaration of Conformity? In other words, should those two documents match standard for standard?  A Standard might be used as a guiding document on the Essential Principles Checklist, but not necessarily 100% conformed to for the DoC.

Thanks for you help

Both Richard and Edward gave excellent advice. I would like to add that in a very successful acquisition that involved me in my position as Director of Quality and Regulatory required development of a 100-day plan prior to the acquisition. What resources and activities would be required in the first 100 days after the acquisition to assure success. It included sending resources to the new acquisition to move their quality system into the new parent companies system, training and quality system documentation updates. Changes to regulatory filings like registration and listing and ownership of 510k were also part of this first 100 days.

It really helped to have a plan in place on how to proceed beginning on Day One of the acquisition so that everyone would know what would happen and who was responsible to accomplish each task as well as when it needed to be completed. 

------------------------------
Edwin Bills MEd, BSc, RAC, ASQ Fellow, CQE, CQA, CMQ/OE
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 18-Nov-2022 04:59
From: Edward Ball
Subject: Essential Principles Checklist Questions

Just to add one little bit to Richard's pretty comprehensive reply.

Do not assume that conformity to a standard is sufficient.

Why do I say that? It depends on the standard and its contents, as well as where that standard sits within the generally acknowledged state of the art. Even the latest version of a fundamental product standard could be a few years behind emerging issues that users, regulators and industry are seeing within the post market surveillance data. As Richard says, the EP/ER/GSPRs are not there for a checklist but are there to drive consideration of known safety and performance issues and are equivalent to the hazard identification process laid out in clause 5 of ISO 14971. The guidance for that standard is given in ISO TR 24971, and Annex E of that guidance provides considerations for how to use standards within the risk management process. The key line from that Annex that I want to highlight is "... can be considered acceptable unless there is objective evidence to the contrary (for example reports of adverse events, product recalls or complaints)". That 'evidence to the contrary' will likely come from your post market surveillance and monitoring of the inputs for what is considered the generally acknowledged state of the art for your device.

------------------------------
Edward Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 18-Nov-2022 02:53
From: Richard Vincins
Subject: Essential Principles Checklist Questions

Hello Anon,

Just as a note, the Essential Principles for IVD devices you might be referring to Australia or GHTF, this is known as General Safety and Performance Requirements (GSPR) in Europe.  Also the term checklist is used, but we know the information contained in a Essential Principles (EP), Essential Requirements (ER), or GSPR, whichever terminology is used, is more than a checklist - more of a matrix for how information supports the safety and performance of a medical device.  To answer your questions, you will find there are quite a variety of positions on this because the use of standards and the version used is often a contentious topic between the company and regulatory reviewer and even within the industry.  Unfortunately there is not a guide or clear statement out there on exactly what is acceptable except phrases like "state of the art" or Good Manufacturing Practice (GMP).  Although you do have some better definitive areas like the US FDA who have their recognised standards database or even guidance in Europe now.

1. My opinion is the EP/ER/GSPR should only list current standards, because of a reason stated above like state of the art.  However, you can still list conformance to previous standards, such as when the actual testing was performed which some companies do. Though with any progression of standards and their usage is the expectation following the current standard, i.e. state of the art or GMP.  What this means is while you can cite conformance to a previous version, internally there should be documentation supporting why this is still acceptable, and why testing has not been performed to the current version.  This is an impact assessment, gap analysis, and type of justification document.  An often used example is ISO 10993-1 where a device developed back in 2007 may have been tested to the version then but the "current" version is 2020.  It does not necessarily mean the device is tested again to current version, but an assessment is performed to determine if additional testing may be required.  In many cases there is a substantial amount of documentation generated.  Again, there are many different views on this and it can be quite involved, this is just a brief thought from myself.
2. For the Declaration of Conformity (DofC), it is commonly understand the "main" product specific standards are listed in the DofC, i.e. IEC 60601-1, ISO 11135, ISO 10993-5/-10, and other product specific testing standards like ISO 80601-2-56 for say thermometers.  As an example, I do not put standards like ISO 13485, ISO 14971, or even like IEC 62304 because these are "quality system" standards which as a medical device company would be expected to comply.  While these standards would be listed in the EP/ER/GSPR matrix, I would not necessarily include them on the DofC.  Again, the view of this can vary so there are different ways this can be done by companies.  In addition, the regulatory authority (Notified Body or Approving Body) may want specific information listed on the DofC as well, including all the standards which may be listed in the matrix.  I have seen this before so the DofC contains an "Appendix" with a complete list of all the standards which are applied for conformity.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 17-Nov-2022 09:07
From: Anonymous Member
Subject: Essential Principles Checklist Questions

This message was posted by a user wishing to remain anonymous

Hello All,

I have a couple of questions regarding the Essential Principles Checklist for IVD devices.

1. If a product was designed and tested years back and previous Standards that have now been revised/withdrawn were used, is it okay to list the withdrawn or outdated Standard as the method of conformity? Due to the fact that the withdrawn standard was technically used at the time of development? Or should the Essential Principles Checklist only list current Standards?

2.  If a Standard is used on the Essential Principles Checklist should it also be listed on the Declaration of Conformity? In other words, should those two documents match standard for standard?  A Standard might be used as a guiding document on the Essential Principles Checklist, but not necessarily 100% conformed to for the DoC.

Thanks for you help