Regulatory Open Forum

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you! 

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device. 

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

To start the thread, I can say that Health Canada requires ISO 13485 (by way of an MDSAP certificate) for the manufacturers of Canadian classes II, III, and IV devices.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

If your companies goals are limited to being a sole supplier to a single customer who will audit your facility regardless, ISO 13485 certification may not be necessary.

If your companies aspirations are loftier, ISO 13485 certification communicates quite a bit to the market.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 13-Oct-2021 13:07
From: Kevin Randall, RAC
Subject: When or where is ISO 13485 certification required?

To start the thread, I can say that Health Canada requires ISO 13485 (by way of an MDSAP certificate) for the manufacturers of Canadian classes II, III, and IV devices.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Thank you all for your helpful comments!

I fully understand the value of compliance with the standard, but I have never worked with such a small company with such a limited budget, where the relative costs associated with certification are actually quite significant.

This is a company that has been selling products for years and don't know what they don't know, and nothing has stopped them from getting the devices out there. Fortunately the new leadership recognizes the inherent value in operating within a QMS. Otherwise I would not have taken on this project. :) So we have been successful getting a QMS in place that is in compliance with the ISO standard.  I wouldn't say it's quite "established" so far but the leadership is committed to it so I'm confident it's just a matter of time. 

However, as you all know, compliance and certification are not the same thing. So I was looking for the benefits of certification so the company can make an informed decision and determine the associated timing and budget.

Thanks again! Very helpful!
Marianne

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
------------------------------

Original Message:
Sent: 13-Oct-2021 14:01
From: Ed Panek
Subject: When or where is ISO 13485 certification required?

If your companies goals are limited to being a sole supplier to a single customer who will audit your facility regardless, ISO 13485 certification may not be necessary.

If your companies aspirations are loftier, ISO 13485 certification communicates quite a bit to the market.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 13-Oct-2021 13:07
From: Kevin Randall, RAC
Subject: When or where is ISO 13485 certification required?

To start the thread, I can say that Health Canada requires ISO 13485 (by way of an MDSAP certificate) for the manufacturers of Canadian classes II, III, and IV devices.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Hi Marianne

Australia also requires MDSAP ISO 13485 Certification.    Brazil, Japan are also part of MDSAP and I think they now require it too (folks correct me on those 2 as necessary)

ISO 13485 is also required in Taiwan, Korea, Singapore, Malaysia, Phillippines-all the ASEAN countries expect it as part of the submission etc..  It  really it is the standard in Asia and Latin America.   India uses it, and for their own local manufacturers they are requiring an Indian version of it soon. 

Europe does NOT require it, but their requirements for quality management systems outlined in Article 10 of the MDR and IVDR are so closely aligned with it, it is extremely useful.   And of course, FDA does not require it, but is moving to adopt it (one decade).

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 13-Oct-2021 13:07
From: Kevin Randall, RAC
Subject: When or where is ISO 13485 certification required?

To start the thread, I can say that Health Canada requires ISO 13485 (by way of an MDSAP certificate) for the manufacturers of Canadian classes II, III, and IV devices.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Good Morning Marianne,

I believe, as many do, that ISO 13485 certification or similar certification is inferred as required in order to sell products into the EU.  We attempted to find an AR for our Class I, non-measuring, non-sterile device and were unable to start the process of MDR compliance until we had our ISO 13485 certificate. 

There are also countries in the Middle East that will not allow import into the country without an ISO 13485 certificate, so depending on where your distributors are, they may be correct.

The certificate is the easiest way to prove that your quality management processes are under control to ensure best practices in everything you do.

Best of luck,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Folks,

I have an additional question with regard to 13485 - what is the difference between EN ISO13485 and ISO 13485 and which one is acceptable to Competant Authorities in Europe?   Can you place product on the market for example with an ISO13485 certification as opposed to an EN ISO13485?
Thanks,
Chris.
Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Be aware that EN ISO 13485:2016 Amd11:2021 has been published. This document will be the Harmonized version of the standard when published in the EUOJ.  On this blog recently it was published that the updated Harmonized standards list will only appear twice a year  

You can obtain this amendment now from your European standards supplier and apply this to your quality system with its Z annexes for MDR and IVDR. I believe the BSI version also has information for application in the UK. 

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal Consultant
------------------------------

Original Message:
Sent: 14-Oct-2021 02:43
From: Anonymous Member
Subject: When or where is ISO 13485 certification required?

This message was posted by a user wishing to remain anonymous

Hi Folks,

I have an additional question with regard to 13485 - what is the difference between EN ISO13485 and ISO 13485 and which one is acceptable to Competant Authorities in Europe?   Can you place product on the market for example with an ISO13485 certification as opposed to an EN ISO13485?
Thanks,
Chris.
Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland
------------------------------

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Thank you, everyone for your replies. I'd like to clarify my request. I am aware of the need for a QMS as a requirement and as best practice, and that certification to ISO 13485 is a typical way to accomplish this. My question is, when is an ISO 13485 Certificate required by a regulatory body? In my experience it is possible to have a QMS that conforms to the standard, to the FDA QSR, and to the MDD and/or MDR requirements without having a third party certify compliance to an ISO QMS standard. It is this distinction that I'm looking for.

Any additional help is appreciated!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
------------------------------

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Marianne 

All my comments for Australia, Canada, ASEAN and other Asian countries,  Latin America, etc.   They absolutely  REQUIRE ISO 13485 certification. 

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 17-Oct-2021 13:11
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Thank you, everyone for your replies. I'd like to clarify my request. I am aware of the need for a QMS as a requirement and as best practice, and that certification to ISO 13485 is a typical way to accomplish this. My question is, when is an ISO 13485 Certificate required by a regulatory body? In my experience it is possible to have a QMS that conforms to the standard, to the FDA QSR, and to the MDD and/or MDR requirements without having a third party certify compliance to an ISO QMS standard. It is this distinction that I'm looking for.

Any additional help is appreciated!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Thanks, Ginger! I really appreciate your time and expertise.

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
------------------------------

Original Message:
Sent: 17-Oct-2021 14:24
From: Ginger Cantor
Subject: When or where is ISO 13485 certification required?

Marianne

All my comments for Australia, Canada, ASEAN and other Asian countries,  Latin America, etc.   They absolutely  REQUIRE ISO 13485 certification.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 17-Oct-2021 13:11
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Thank you, everyone for your replies. I'd like to clarify my request. I am aware of the need for a QMS as a requirement and as best practice, and that certification to ISO 13485 is a typical way to accomplish this. My question is, when is an ISO 13485 Certificate required by a regulatory body? In my experience it is possible to have a QMS that conforms to the standard, to the FDA QSR, and to the MDD and/or MDR requirements without having a third party certify compliance to an ISO QMS standard. It is this distinction that I'm looking for.

Any additional help is appreciated!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

You can certainly achieve a QMS without conforming to ISO 13485.  Without a third-party evaluation of your system, then we may not be talking about an ISO 13485 audit, but rather than inspection by the regulatory authority against some government criteria.  Quite recently, 5 countries have opted for the MDSAP route (note MDSAP is just a different auditing methodology based on ISO 13485) to give companies the option of achieving MDSAP ISO 13485 compliance with a certificate issued by a third-party.  Canada is the only country of the five that mandates MDSAP ISO 13485, so there isn't the option of having Health Canada come in to inspect the manufacturer's facilities (Class II, III, IV) instead of a third-party body.  Canada relies on the third-party auditing organizations as demonstration of a QMS conforming to ISO 13485 requirements.  You can say that at least in Canada, ISO 13485 certification is  absolutely required by the regulatory body to market Class II-IV devices. 

I hope I answered your question.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 17-Oct-2021 13:11
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Thank you, everyone for your replies. I'd like to clarify my request. I am aware of the need for a QMS as a requirement and as best practice, and that certification to ISO 13485 is a typical way to accomplish this. My question is, when is an ISO 13485 Certificate required by a regulatory body? In my experience it is possible to have a QMS that conforms to the standard, to the FDA QSR, and to the MDD and/or MDR requirements without having a third party certify compliance to an ISO QMS standard. It is this distinction that I'm looking for.

Any additional help is appreciated!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Karen

Australia also mandates MSDAP ISO 13485:2016, since 2018.


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 19-Oct-2021 17:59
From: Karen Zhou
Subject: When or where is ISO 13485 certification required?

You can certainly achieve a QMS without conforming to ISO 13485.  Without a third-party evaluation of your system, then we may not be talking about an ISO 13485 audit, but rather than inspection by the regulatory authority against some government criteria.  Quite recently, 5 countries have opted for the MDSAP route (note MDSAP is just a different auditing methodology based on ISO 13485) to give companies the option of achieving MDSAP ISO 13485 compliance with a certificate issued by a third-party.  Canada is the only country of the five that mandates MDSAP ISO 13485, so there isn't the option of having Health Canada come in to inspect the manufacturer's facilities (Class II, III, IV) instead of a third-party body.  Canada relies on the third-party auditing organizations as demonstration of a QMS conforming to ISO 13485 requirements.  You can say that at least in Canada, ISO 13485 certification is  absolutely required by the regulatory body to market Class II-IV devices.

I hope I answered your question.

------------------------------
Karen Zhou

Original Message:
Sent: 17-Oct-2021 13:11
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Thank you, everyone for your replies. I'd like to clarify my request. I am aware of the need for a QMS as a requirement and as best practice, and that certification to ISO 13485 is a typical way to accomplish this. My question is, when is an ISO 13485 Certificate required by a regulatory body? In my experience it is possible to have a QMS that conforms to the standard, to the FDA QSR, and to the MDD and/or MDR requirements without having a third party certify compliance to an ISO QMS standard. It is this distinction that I'm looking for.

Any additional help is appreciated!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Hi Margit

you said "Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked."

Does that mean (it sounds like it does) that those additional requirements (Art 10) are addressed/mentioned specifically in the EN ISO 13485:2016?

I have not yet seen/read the new EN version.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland
------------------------------

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Dear Enrico,
In the (EN) ISO 13485:2016 the term 'regulatory requirements' exploded in the new version from 5 to approximately 69 times. The regulatory requirements has to defined by every manufacturer - for Europe the regulatory requirements are know MDR and for requirements of the QMS MDR §10(9). A gap analysis to the requirements of the standard EN ISO 13485:2016 to MDR §10(9) you will find in A11:2021. Thus for every CE-marked medical device the regulatory requirements of the MDR / IVDR has to be fulfilled.

For class I medical devices MDR §10 is also legally binding, therefor they need also now a full QMS acc. EN ISO 13485:2016 A11:2021 and MDR §10(9), which was no required under the Directives.

Hope this helps
Margit

------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland
------------------------------

Original Message:
Sent: 18-Oct-2021 05:06
From: Enrico Schurig
Subject: When or where is ISO 13485 certification required?

Hi Margit

you said "Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked."

Does that mean (it sounds like it does) that those additional requirements (Art 10) are addressed/mentioned specifically in the EN ISO 13485:2016?

I have not yet seen/read the new EN version.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

Dear Margit,

Thanks for the info.

"A gap analysis to the requirements of the standard EN ISO 13485:2016 to MDR §10(9) you will find in A11:2021".
Ok, that's what I was looking for. I have to check this out soon.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland
------------------------------

Original Message:
Sent: 18-Oct-2021 07:29
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Enrico,
In the (EN) ISO 13485:2016 the term 'regulatory requirements' exploded in the new version from 5 to approximately 69 times. The regulatory requirements has to defined by every manufacturer - for Europe the regulatory requirements are know MDR and for requirements of the QMS MDR §10(9). A gap analysis to the requirements of the standard EN ISO 13485:2016 to MDR §10(9) you will find in A11:2021. Thus for every CE-marked medical device the regulatory requirements of the MDR / IVDR has to be fulfilled.

For class I medical devices MDR §10 is also legally binding, therefor they need also now a full QMS acc. EN ISO 13485:2016 A11:2021 and MDR §10(9), which was no required under the Directives.

Hope this helps
Margit

------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 18-Oct-2021 05:06
From: Enrico Schurig
Subject: When or where is ISO 13485 certification required?

Hi Margit

you said "Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked."

Does that mean (it sounds like it does) that those additional requirements (Art 10) are addressed/mentioned specifically in the EN ISO 13485:2016?

I have not yet seen/read the new EN version.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

The Annexes ZA, ZB in the standard have a table indicating what elements of the GSPR are covered or not covered by the standard. I would not exactly call this a gap analysis. Additionally, there are several notes that are important to review as you implement your quality system for the MDR or IVDR.

Ed Bills
843-810-2157
Sent from my iPhone


Original Message:
Sent: 10/19/2021 4:04:00 AM
From: Enrico Schurig
Subject: RE: When or where is ISO 13485 certification required?

Dear Margit,

Thanks for the info.

"A gap analysis to the requirements of the standard EN ISO 13485:2016 to MDR §10(9) you will find in A11:2021".
Ok, that's what I was looking for. I have to check this out soon.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland
------------------------------

Original Message:
Sent: 18-Oct-2021 07:29
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Enrico,
In the (EN) ISO 13485:2016 the term 'regulatory requirements' exploded in the new version from 5 to approximately 69 times. The regulatory requirements has to defined by every manufacturer - for Europe the regulatory requirements are know MDR and for requirements of the QMS MDR §10(9). A gap analysis to the requirements of the standard EN ISO 13485:2016 to MDR §10(9) you will find in A11:2021. Thus for every CE-marked medical device the regulatory requirements of the MDR / IVDR has to be fulfilled.

For class I medical devices MDR §10 is also legally binding, therefor they need also now a full QMS acc. EN ISO 13485:2016 A11:2021 and MDR §10(9), which was no required under the Directives.

Hope this helps
Margit

------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 18-Oct-2021 05:06
From: Enrico Schurig
Subject: When or where is ISO 13485 certification required?

Hi Margit

you said "Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked."

Does that mean (it sounds like it does) that those additional requirements (Art 10) are addressed/mentioned specifically in the EN ISO 13485:2016?

I have not yet seen/read the new EN version.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


------------------------------
Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------

A bit of confusion here. EN ISO 13485:2016 Amd11:2021 is the latest version and has been submitted to be Harmonized, but not yet published in the Official Journal, so it is not yet Harmonized.

So that is the Technical Response. HOWEVER, the Amd11 version has fulfilled all the requirements to be Harmonized, and should be the choice for manufacturers that are selling medical devices or IVDs in the EU. This version is not required anywhere else in the world, so if you don’t sell in EU, use ISO 13485:2016, as that is sufficient, UNLESS, the regulatory authority of the country requires the EN version.

Ed Bills
843-810-2157
Sent from my iPhone


Original Message:
Sent: 10/18/2021 5:07:00 AM
From: Enrico Schurig
Subject: RE: When or where is ISO 13485 certification required?

Hi Margit

you said "Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked."

Does that mean (it sounds like it does) that those additional requirements (Art 10) are addressed/mentioned specifically in the EN ISO 13485:2016?

I have not yet seen/read the new EN version.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Le Mont-sur-Lausanne
Switzerland
------------------------------

Original Message:
Sent: 16-Oct-2021 12:02
From: Margit Widmann
Subject: When or where is ISO 13485 certification required?

Dear Marianne,
In conclusion as mentioned already before, a ISO 13485:2016 certificate is necessary for MDSAP countries.
FDA requires a quality management in 21 CFR 820 which is mandatory . With the EU-regulation MDR 2017/745/EU and IVDR 2017/746/EU a quality management is also now legally binding for all manufacturers MDR §10(9) and IVDR §10(8). However in Europe you need the EN ISO 13485:2016, as this standard is harmonized (see https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)Only «EN» standards can be harmonized and have in consequence the annex Z's, as Edwin mentioned. Annex ZA-ZC show the relationship to the requirements to the EU-directives, Annex ZD and ZE which is published now as A11:2021 showing the relationship of the EU-Regulation to §10 (=obligations of manufacturers) of MDR / IVDR  to the standard as well as to the conformity procedure assessments Annex IX and XI. A certificate to EN ISO 13485:2016 especially is not demanded, however most of the manufacturer has a certificate to EN ISO 13485:2016. This is important, as § 10 of the EU-regulations requires more than the standard demands. Art 10 has to be fulfilled by all manufacturer, also Class I manufacturers, which is new for them. All European manufacturers need the EN ISO 13485:2016, as the plus of requirements required by the EU-regulation has to be fulfilled by all medical devices and IVD which will be CE-marked.
The economic operators like a distributor or EC-REP also have to have processes e.g. for complaints and reporting (vigilance) etc., in order to fulfill the obligations of MDR §11, 14. Distributors according MDR §16 now can also get a certification for the QMS. The instruction for NB is given in the MDCG 2021-23 (Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission).
Under Vademecum on European standardisation - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  there is a good overview to the standards as well the list for M575, the standardization request for Medical Devices Standardisation requests - mandates - Internal Market, Industry, Entrepreneurship and SMEs - European Commission  under EU-Regulation.
Hope this helps.
Best regards
Margit


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Margit Widmann MD
Director Regulatory
Günsberg
Switzerland

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
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In Russia Legal and all physical manufactureres must be ISO 13485 certified. The same in many ex-USSR countries (Belarus, Kazakhstan, Uzbekistan etc.)

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Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 13-Oct-2021 12:51
From: Marianne Jacklyn
Subject: When or where is ISO 13485 certification required?

Dear Community,

First, I follow these threads daily and learn so much from contributors, so thank you!

I am working with a small company that has a QMS that follows ISO 13485:2016 but is evaluating the cost/benefit of obtaining certification. We understand that the standard is voluntary, but I have been informed by a few distributors that some regulatory authorities rely on this certification as part of the registration process. For context, this is a Class I, non-sterile OTC device.

Do some regulatory authorities require certification to this (or other) standards? And, if so, does anyone have a list of those that do that they would be willing to share?

I didn't find a previous thread for this, but if I missed it please direct me.

Many thanks in advance!

------------------------------
Marianne Jacklyn
West Linn OR
United States
------------------------------