Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

I'll answer from the point of view of the EU-MDR. The same applies to the EU-MDD, but it doesn't have the details of the EU-MDR.

The EU-MDR doesn't use the term "legal manufacturer", only "manufacturer".

I infer you are located in Canada, not the EU.

The manufacturer is responsible to include include risk management as as part of the QMS according to Article 10. There are specific details in Annex I. There is information in EN ISO 14971:2019/A11:2021.

There are no explicit requirements for a distributor in risk management. However, the distributor should report complaints and other information to the manufacturer who would then is it in the risk management process.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

Health Canada's requirements for Canadian importers and distributors are governed by Health Canada's legislative requirements, not Europe's EU-MDR, nor by any other European requirement.  Canada and Europe are separate regulatory jurisdictions, with separate requirements. While there may be some similarities, it is unwise and misleading to explain or assert EU-MDR requirements or legislation for Canadian jurisdictional requirements.

The Canadian Medical Devices Regulations (CMDR) impose risk management requirements on the manufacturer, but not the distributor or importer.

With respect to complaint handling, the CMDR allow Canadian distributors and importers to choose what investigation method is best.  That may or may not involve reporting to the manufacturer.

Also, beware of the notion of limiting the focus of a Canadian distributor's or importer's quality management system to only complaint handling.  This is an example of the danger of misusing Europe's legislative / jurisdictional requirements for Canada.  Specifically, Health Canada requires Canadian importers and distributors to have a quality management system addressing not just complaint handling, but also procedures, as applicable depending on device risk class, for distribution records, handling, storage, delivery, recall, installation, servicing, incident reporting, corrective action, and serious risk of injury to human health.

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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Nov-2022 10:25
From: Dan O'Leary
Subject: Responsibility for Risk Management Documents

I'll answer from the point of view of the EU-MDR. The same applies to the EU-MDD, but it doesn't have the details of the EU-MDR.

The EU-MDR doesn't use the term "legal manufacturer", only "manufacturer".

I infer you are located in Canada, not the EU.

The manufacturer is responsible to include include risk management as as part of the QMS according to Article 10. There are specific details in Annex I. There is information in EN ISO 14971:2019/A11:2021.

There are no explicit requirements for a distributor in risk management. However, the distributor should report complaints and other information to the manufacturer who would then is it in the risk management process.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

If you are talking about the Risk Management File and the documents contained therein, the responsibility is the manufacturer. The way it has been explained to me by a well-known regulator is that the (legal) person whose name is on the product is responsible for everything in the product including all documentation. 

I usually find Kevin's explanations to be on target with sufficient detail to explain the issue so that even I can understand. 

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

Original Message:
Sent: 11-Nov-2022 10:25
From: Dan O'Leary
Subject: Responsibility for Risk Management Documents

I'll answer from the point of view of the EU-MDR. The same applies to the EU-MDD, but it doesn't have the details of the EU-MDR.

The EU-MDR doesn't use the term "legal manufacturer", only "manufacturer".

I infer you are located in Canada, not the EU.

The manufacturer is responsible to include include risk management as as part of the QMS according to Article 10. There are specific details in Annex I. There is information in EN ISO 14971:2019/A11:2021.

There are no explicit requirements for a distributor in risk management. However, the distributor should report complaints and other information to the manufacturer who would then is it in the risk management process.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

Assuming as you are the importer and distributor, you also are the Medical Device LIcense holder for Canada, you need to ensure your supplier (the manufacturer) meets the applicable requirements as well. I would refer you to the guidance from Health Canada for Medical Devices HERE

In addition, you should have the appropriate agreements (written quality agreements) to ensure the information is maintained and how communication (changes or issues) is addressed.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

Canadian Medical Device Licenses don't apply to importers and distributors.  Instead, only manufacturers hold Canadian Medical Device Licenses.  Be sure not to apply such requirements to importers or distributors, as those requirements are reserved for manufacturers.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-Nov-2022 08:00
From: Mark Swanson
Subject: Responsibility for Risk Management Documents

Assuming as you are the importer and distributor, you also are the Medical Device LIcense holder for Canada, you need to ensure your supplier (the manufacturer) meets the applicable requirements as well. I would refer you to the guidance from Health Canada for Medical Devices HERE

In addition, you should have the appropriate agreements (written quality agreements) to ensure the information is maintained and how communication (changes or issues) is addressed.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.

Echoing what others have said, the risk management documents (file) specific to the product that is required as part of regulatory requirements is the responsibility of the manufacturer/legal manufacturer.

From a common sense and best practice approach, within a certified quality management system or not, any other economic operator should consider the context of their operations, processes and activities and then the potential impact on the medical device(s). E.g. are packaging systems opened and pack contents divided or split? Are devices collated together to form customer specific kits? Are sterile barriers breached? Are protective packaging removed or altered? Are any labels or information added to the device or packaging? Is the customer/end-user provided with all of the information for use supplied by the device manufacturer? etc etc.

How to do it? ISO 14971:2019 addresses it as part of the scope "The process described in this document... can also be used by others involved in the medical device life cycle."

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Edward Ball
Manager, Intelligence & Innovation
United Kingdom
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Original Message:
Sent: 11-Nov-2022 10:02
From: Anonymous Member
Subject: Responsibility for Risk Management Documents

This message was posted by a user wishing to remain anonymous

I'm the importer and the distributor of a CE marked medical device in Canada. My question is do I have any responsibility for risk management documents or  does the legal manufacturer have responsibility for risk management?  As always this forum is a fantastic resource to share your knowledge, thank you for your replies.