Regulatory Open Forum

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!

In short, no, the US FDA doesn't, as a general rule, require us to have a Declaration of Conformity (DoC) such as in the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an "Abbreviated 510(k)".  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls "general use" of consensus standards.  "General use" means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn't be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe's "EN" standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Apr-2023 21:39
From: Anonymous Member
Subject: Declaration of Conformity

This message was posted by a user wishing to remain anonymous

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!

Just fixed the 17050-1 typo.

In short, no, the US FDA doesn't, as a general rule, require us to have a Declaration of Conformity (DoC) such as in the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an "Abbreviated 510(k)".  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls "general use" of consensus standards.  "General use" means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn't be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe's "EN" standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Apr-2023 21:39
From: Anonymous Member
Subject: Declaration of Conformity

This message was posted by a user wishing to remain anonymous

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!

Hello,

Sorry Kevin, I have to sort of clarify declaration of conformity and circumstances you provided.

- A Declaration of Conformity for the EU MDR 2017/745 follows Annex IV (and in the previous EU MDD); there is a defined structured there and expected content by Notified Bodies.  In fact, some Notified Bodies have a recommended structure they want companies to use.
- A Declaration of Conformity to voluntary or recognised standards by the US FDA for use in premarket applications such as 510(k) is something different.  There is specific information related to conformity to a standard provided in the premarket application such as full/part compliance, accreditation by external parties, and other information.  This is not a post market document.  And it is not the same as a Declaration of Conformity in the EU, I do not believe a hybrid could be used as the content is completely different.
- A Declaration of Conformity a company uses specific to their product would define product specifications, acceptance criteria, and how these were met for their product.  This could be done for the entire product line or say batch-to-batch or by lot.  This is typically something required by a customer or something by the product type, such as materials in the device or composition of the device.  This could potentially be combined with the Declaration of Conformity in the EU, but would definitely gain acceptance by your Notified Body (if using one).  In this case, could use ISO 17050-1 for the structure and content.
- A Declaration of Conformity a supplier/vendor provides to a company for their raw materials, components, or product would define product specifications, acceptance criteria, and how these were met for their product.  From a supplier the ISO 17050-1 can definitely (and should be) used for the structure and content.  Keep in mind ISO 17050-1 is an international standard and not specific to medical devices, so this is used in many other industries.  The terms Certificate of Conformity or Certificate of Conformance are also used synonymously in a supplier of materials situation.  (There is also the Certificate of Analysis which is often used synonymously, but for me is different.)

I do agree the Europe CE Mark and US FDA use of declaration of conformities should not be mixed.  These are two different regulatory approaches and used for different purposes.

Just fixed the 17050-1 typo.

In short, no, the US FDA doesn't, as a general rule, require us to have a Declaration of Conformity (DoC) such as in the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an "Abbreviated 510(k)".  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls "general use" of consensus standards.  "General use" means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn't be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe's "EN" standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Apr-2023 21:39
From: Anonymous Member
Subject: Declaration of Conformity

This message was posted by a user wishing to remain anonymous

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!

Hi Richard, many thanks for your clarifications.  I must have gotten you (and maybe others) confused.  Let me clarify:

I think that most everyone knows that Annex IV of the EU MDR/IVDR prescribes the exact elements for an EU MDR/IVDR DoC.  But Anon isn't asking how to do an EU MDR/IVDR DoC, nor about what are the precise elements of an EU MDR/IVDR DoC.  Instead, Anon asked about combining a US DoC with an EU MDR DoC.  Accordingly, for such comparative purposes (U.S. vs. EU), it is for two reasons quite germane that an EU MDR/IVDR DoC it is fundamentally modeled after (not the same as, but modeled after) EN ISO 17050-1.  Specifically:

a) EN ISO 17050-1 and Europe's common framework are the traditional basis that gave rise to Annex IV.  For example, the Blue Guide reminds us of that when it states, "...The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity...". Prior to EU MDR  Annex IV's prescription, notified body's used EN ISO 17050-1 as the basis for auditing MDD DoCs.  Again, it is correct that the exact requirements for an EU MDR/IVDR DoC are prescribed by Annex IV, but again that is not Anon's question.

b) The U.S. FDA's stated policy is that, "...To certify conformance with a consensus standard, the submitter must submit a DOC...These elements of a DOC are consistent with ISO/IEC 17050-1..."

Accordingly, my answer to Anon's question about the logistical aspect of combining a U.S. and EU DoC into a single document is certainly correct.  But again as I mentioned in my first post: Because of the fundamentally different statutory/legislative reasons for a U.S. vs. EU DoC, I don't recommend such a hybridized approach.

On that note, I certainly agree with you that a U.S. DoC "is something different".  Specifically, see my initial post distinguishing the differences between the way the U.S uses DoCs [e.g., for the statutory purposes of section 510(k) of the FD&C Act] vs. the way the EU uses it (i.e., for EU MDR / IVDR conformity assessment).

Your narrative, "[A U.S. DoC] is not a post market document" [emphasis added] seems to indicate that you are saying that an EU MDR/IVDR DoC is a post market document.  But that would be incorrect.  Instead, an EU MDR/UVDR DoC must be drawn up before placing the devices on the market.

Regarding your use of the name 'Declaration of Conformity' for, "...a company uses specific to their product would define product specifications, acceptance criteria, and how these were met for their product...", my experience is that such a document is instead called a Certificate of Conformity (CoC), Certificate of Analysis (CoA), or something similar.  I've not heard of, or seen, such a document being called a 'Declaration of Conformity' though you must have.  But to avoid confusion with the more proper, conventional, and legislative use of 'Declaration of Conformity', I would recommend against using 'Declaration of Conformity' for a CoC/CoA.

Hello,

Sorry Kevin, I have to sort of clarify declaration of conformity and circumstances you provided.

- A Declaration of Conformity for the EU MDR 2017/745 follows Annex IV (and in the previous EU MDD); there is a defined structured there and expected content by Notified Bodies.  In fact, some Notified Bodies have a recommended structure they want companies to use.
- A Declaration of Conformity to voluntary or recognised standards by the US FDA for use in premarket applications such as 510(k) is something different.  There is specific information related to conformity to a standard provided in the premarket application such as full/part compliance, accreditation by external parties, and other information.  This is not a post market document.  And it is not the same as a Declaration of Conformity in the EU, I do not believe a hybrid could be used as the content is completely different.
- A Declaration of Conformity a company uses specific to their product would define product specifications, acceptance criteria, and how these were met for their product.  This could be done for the entire product line or say batch-to-batch or by lot.  This is typically something required by a customer or something by the product type, such as materials in the device or composition of the device.  This could potentially be combined with the Declaration of Conformity in the EU, but would definitely gain acceptance by your Notified Body (if using one).  In this case, could use ISO 17050-1 for the structure and content.
- A Declaration of Conformity a supplier/vendor provides to a company for their raw materials, components, or product would define product specifications, acceptance criteria, and how these were met for their product.  From a supplier the ISO 17050-1 can definitely (and should be) used for the structure and content.  Keep in mind ISO 17050-1 is an international standard and not specific to medical devices, so this is used in many other industries.  The terms Certificate of Conformity or Certificate of Conformance are also used synonymously in a supplier of materials situation.  (There is also the Certificate of Analysis which is often used synonymously, but for me is different.)

I do agree the Europe CE Mark and US FDA use of declaration of conformities should not be mixed.  These are two different regulatory approaches and used for different purposes.

Just fixed the 17050-1 typo.

In short, no, the US FDA doesn't, as a general rule, require us to have a Declaration of Conformity (DoC) such as in the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an "Abbreviated 510(k)".  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls "general use" of consensus standards.  "General use" means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn't be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe's "EN" standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Apr-2023 21:39
From: Anonymous Member
Subject: Declaration of Conformity

This message was posted by a user wishing to remain anonymous

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!

Hi all

To Kevin's point of DoC vs. CoC: my understanding is that a company, supplier, ... can declare something in writing. However, only some entity that is accredited can certify. Thus, a company issues a declaration, an accedited lab issues a type test certificate.

Can you support this?

Hi Richard, many thanks for your clarifications.  I must have gotten you (and maybe others) confused.  Let me clarify:

I think that most everyone knows that Annex IV of the EU MDR/IVDR prescribes the exact elements for an EU MDR/IVDR DoC.  But Anon isn't asking how to do an EU MDR/IVDR DoC, nor about what are the precise elements of an EU MDR/IVDR DoC.  Instead, Anon asked about combining a US DoC with an EU MDR DoC.  Accordingly, for such comparative purposes (U.S. vs. EU), it is for two reasons quite germane that an EU MDR/IVDR DoC it is fundamentally modeled after (not the same as, but modeled after) EN ISO 17050-1.  Specifically:

a) EN ISO 17050-1 and Europe's common framework are the traditional basis that gave rise to Annex IV.  For example, the Blue Guide reminds us of that when it states, "...The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity...". Prior to EU MDR  Annex IV's prescription, notified body's used EN ISO 17050-1 as the basis for auditing MDD DoCs.  Again, it is correct that the exact requirements for an EU MDR/IVDR DoC are prescribed by Annex IV, but again that is not Anon's question.

b) The U.S. FDA's stated policy is that, "...To certify conformance with a consensus standard, the submitter must submit a DOC...These elements of a DOC are consistent with ISO/IEC 17050-1..."

Accordingly, my answer to Anon's question about the logistical aspect of combining a U.S. and EU DoC into a single document is certainly correct.  But again as I mentioned in my first post: Because of the fundamentally different statutory/legislative reasons for a U.S. vs. EU DoC, I don't recommend such a hybridized approach.

On that note, I certainly agree with you that a U.S. DoC "is something different".  Specifically, see my initial post distinguishing the differences between the way the U.S uses DoCs [e.g., for the statutory purposes of section 510(k) of the FD&C Act] vs. the way the EU uses it (i.e., for EU MDR / IVDR conformity assessment).

Your narrative, "[A U.S. DoC] is not a post market document" [emphasis added] seems to indicate that you are saying that an EU MDR/IVDR DoC is a post market document.  But that would be incorrect.  Instead, an EU MDR/UVDR DoC must be drawn up before placing the devices on the market.

Regarding your use of the name 'Declaration of Conformity' for, "...a company uses specific to their product would define product specifications, acceptance criteria, and how these were met for their product...", my experience is that such a document is instead called a Certificate of Conformity (CoC), Certificate of Analysis (CoA), or something similar.  I've not heard of, or seen, such a document being called a 'Declaration of Conformity' though you must have.  But to avoid confusion with the more proper, conventional, and legislative use of 'Declaration of Conformity', I would recommend against using 'Declaration of Conformity' for a CoC/CoA.

Hello,

Sorry Kevin, I have to sort of clarify declaration of conformity and circumstances you provided.

- A Declaration of Conformity for the EU MDR 2017/745 follows Annex IV (and in the previous EU MDD); there is a defined structured there and expected content by Notified Bodies.  In fact, some Notified Bodies have a recommended structure they want companies to use.
- A Declaration of Conformity to voluntary or recognised standards by the US FDA for use in premarket applications such as 510(k) is something different.  There is specific information related to conformity to a standard provided in the premarket application such as full/part compliance, accreditation by external parties, and other information.  This is not a post market document.  And it is not the same as a Declaration of Conformity in the EU, I do not believe a hybrid could be used as the content is completely different.
- A Declaration of Conformity a company uses specific to their product would define product specifications, acceptance criteria, and how these were met for their product.  This could be done for the entire product line or say batch-to-batch or by lot.  This is typically something required by a customer or something by the product type, such as materials in the device or composition of the device.  This could potentially be combined with the Declaration of Conformity in the EU, but would definitely gain acceptance by your Notified Body (if using one).  In this case, could use ISO 17050-1 for the structure and content.
- A Declaration of Conformity a supplier/vendor provides to a company for their raw materials, components, or product would define product specifications, acceptance criteria, and how these were met for their product.  From a supplier the ISO 17050-1 can definitely (and should be) used for the structure and content.  Keep in mind ISO 17050-1 is an international standard and not specific to medical devices, so this is used in many other industries.  The terms Certificate of Conformity or Certificate of Conformance are also used synonymously in a supplier of materials situation.  (There is also the Certificate of Analysis which is often used synonymously, but for me is different.)

I do agree the Europe CE Mark and US FDA use of declaration of conformities should not be mixed.  These are two different regulatory approaches and used for different purposes.

Just fixed the 17050-1 typo.

In short, no, the US FDA doesn't, as a general rule, require us to have a Declaration of Conformity (DoC) such as in the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an "Abbreviated 510(k)".  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls "general use" of consensus standards.  "General use" means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn't be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe's "EN" standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Apr-2023 21:39
From: Anonymous Member
Subject: Declaration of Conformity

This message was posted by a user wishing to remain anonymous

Hi all,

Wondering if US FDA requires us to have a Declaration of Conformity such as in the EU? I know that during the submission (510K) you do have to declare the recognized standards.

Also, if we do then can we combine both US and EU into one Declaration of Conformity?

Thank you!