Regulatory Open Forum

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

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Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
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The boundary of the EU MDR requirement for post-market surveillance (along with various other EU MDR requirements) is legislatively driven by the EU MDR's 'placing on the market' concept [see Article 2(28)] and also its related 'making available on the market' and its 'putting into service' concepts.  These are shipment/unit-based concepts rather than model/type-based concepts.

In specific regard to post-market surveillance, the EU MDR requirement is to proactively collect and review experience gained from devices placed on the market, made available on the market, or put into service.  Accordingly, if no devices remain in the marketplace, then that is the delineation for when corresponding post-market surveillance activities can start to be wound down.  But a caveat is that, if additional post-market feedback is received from the marketplace even after no units remain in the marketplace, then such feedback still needs to be received, recorded, and processed as post-market surveillance.  Examples include, but may no be limited to, complaints and serious incident reporting.

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------

Hi Carrie, 

End of life period of device is when, the medical device can no longer be operated safely and perform as intended due to a lack of maintenance and repair and may have to be taken out of operation or withdrawn from the market by the operator. Till that time all PMS is expected to be active. Since the product is discontinued and only repair activity is being carried out in your case - the following PMS  apply 

1. Complaints (including malfunction and adverse events reporting)
2. Device maintenance/refurbishing/repair records (which ever is  applicable)
3. Analysis of returned device (with or without an associated complaint event)

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------

Hi Carrie

Per article 83, "The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions."

If you have installed some radiation therapy equipment, for example, that may continue in service for thirty years before being decommissioned, your surveillance activities need to continue over that whole lifetime.

Although you may be no longer manufacturing or installing that model, things you learn about it over its lifetime may lead you to change the design of newer types of equipment. And you retain responsibilities for the aging equipment, as needed updating the instructions for use, performing necessary upgrades, or recommending it be withdrawn from service.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 15-Feb-2023 16:38
From: Rajeswari Devanathan
Subject: EU MDR PMS After Product Discontinuation

Hi Carrie, 

End of life period of device is when, the medical device can no longer be operated safely and perform as intended due to a lack of maintenance and repair and may have to be taken out of operation or withdrawn from the market by the operator. Till that time all PMS is expected to be active. Since the product is discontinued and only repair activity is being carried out in your case - the following PMS  apply 

1. Complaints (including malfunction and adverse events reporting)
2. Device maintenance/refurbishing/repair records (which ever is  applicable)
3. Analysis of returned device (with or without an associated complaint event)

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Anne,

I have been redirected to this conversation via another feed which is very useful as we are currently undergoing a similar case as to the one described above.

If i may jump in here and post an additional query.

We have a legal manufacturer, based outside of the EU that currently provides IVDD List A and List B devices as CE marked devices, making use of the IVDR transitional period. The decision has been made to cease supply to the EU from this site and close the legal manufacturing site with one of our other sites taking over as the legal manufacturer for the IVDR. The current EC certificate of the current legal manufacturer will be allowed to expire as all devices shall be with the importer and 'placed on the market'. Now, i understand that document retention obligations covering the devices currently on the market shall fall to the EC Rep, but regarding the vigilance/PMS obligations for these devices, can this be transferred to the new legal manufacturer? If there is a lag period between the closure of the current site, and the approval under the IVDR for the new legal manufacturer, will the vigilance/PMS obligations remain with the current manufacturer meaning the site must be maintained in some form until the IVDR certification is achieved by the new legal manufacturer?

Hope my query makes sense.

Appreciate your insight.

Original Message:
Sent: 20-Feb-2023 10:05
From: Anne LeBlanc
Subject: EU MDR PMS After Product Discontinuation

Hi Carrie

Per article 83, "The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions."

If you have installed some radiation therapy equipment, for example, that may continue in service for thirty years before being decommissioned, your surveillance activities need to continue over that whole lifetime.

Although you may be no longer manufacturing or installing that model, things you learn about it over its lifetime may lead you to change the design of newer types of equipment. And you retain responsibilities for the aging equipment, as needed updating the instructions for use, performing necessary upgrades, or recommending it be withdrawn from service.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 15-Feb-2023 16:38
From: Rajeswari Devanathan
Subject: EU MDR PMS After Product Discontinuation

Hi Carrie, 

End of life period of device is when, the medical device can no longer be operated safely and perform as intended due to a lack of maintenance and repair and may have to be taken out of operation or withdrawn from the market by the operator. Till that time all PMS is expected to be active. Since the product is discontinued and only repair activity is being carried out in your case - the following PMS  apply 

1. Complaints (including malfunction and adverse events reporting)
2. Device maintenance/refurbishing/repair records (which ever is  applicable)
3. Analysis of returned device (with or without an associated complaint event)

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------

Hi Anon

I'm not sure if I'm understanding all the details of your situation... It sounds like there are two manufacturing sites under your control, perhaps owned by or in some kind of agreement with a parent organization? And the designs will be transferred from one site to the other?  And the new site will transition to IVDR. And you would like the new site to take over complaint handling and related activities from the old site?

I don't know any reason that couldn't be done. For sure I'd write a quality plan covering all the roles and responsibilities, requiring appropriate procedures to be documented and necessary information transferred.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 21-Feb-2023 01:46
From: Anonymous Member
Subject: EU MDR PMS After Product Discontinuation

This message was posted by a user wishing to remain anonymous

Hi Anne,

I have been redirected to this conversation via another feed which is very useful as we are currently undergoing a similar case as to the one described above.

If i may jump in here and post an additional query.

We have a legal manufacturer, based outside of the EU that currently provides IVDD List A and List B devices as CE marked devices, making use of the IVDR transitional period. The decision has been made to cease supply to the EU from this site and close the legal manufacturing site with one of our other sites taking over as the legal manufacturer for the IVDR. The current EC certificate of the current legal manufacturer will be allowed to expire as all devices shall be with the importer and 'placed on the market'. Now, i understand that document retention obligations covering the devices currently on the market shall fall to the EC Rep, but regarding the vigilance/PMS obligations for these devices, can this be transferred to the new legal manufacturer? If there is a lag period between the closure of the current site, and the approval under the IVDR for the new legal manufacturer, will the vigilance/PMS obligations remain with the current manufacturer meaning the site must be maintained in some form until the IVDR certification is achieved by the new legal manufacturer?

Hope my query makes sense.

Appreciate your insight.

Original Message:
Sent: 20-Feb-2023 10:05
From: Anne LeBlanc
Subject: EU MDR PMS After Product Discontinuation

Hi Carrie

Per article 83, "The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions."

If you have installed some radiation therapy equipment, for example, that may continue in service for thirty years before being decommissioned, your surveillance activities need to continue over that whole lifetime.

Although you may be no longer manufacturing or installing that model, things you learn about it over its lifetime may lead you to change the design of newer types of equipment. And you retain responsibilities for the aging equipment, as needed updating the instructions for use, performing necessary upgrades, or recommending it be withdrawn from service.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 15-Feb-2023 16:38
From: Rajeswari Devanathan
Subject: EU MDR PMS After Product Discontinuation

Hi Carrie, 

End of life period of device is when, the medical device can no longer be operated safely and perform as intended due to a lack of maintenance and repair and may have to be taken out of operation or withdrawn from the market by the operator. Till that time all PMS is expected to be active. Since the product is discontinued and only repair activity is being carried out in your case - the following PMS  apply 

1. Complaints (including malfunction and adverse events reporting)
2. Device maintenance/refurbishing/repair records (which ever is  applicable)
3. Analysis of returned device (with or without an associated complaint event)

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------

Hi Carrie,

I agree with Anne's statement: The PMS activities need to continue over the lifetime of the device and even though this specific model might have been discontinued, the results may give you information applicable to newer devices.

One thing I would like to add: MDCG 2022-21 that deals with the PSUR has this to say about the device lifetime (under 3.2.1): "A PSUR is required throughout the lifetime of the device: The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use / in use. If the lifetime exceeds the administrative provisions in Annexes IX, X, XI, XIII of MDR, i.e. max 10 years for non-implantable devices and max 15 years for implantable devices, then the shorter timeline between the lifetime of the device and the retention period should prevail."

The last sentence seems to indicate that - at least for the purpose of drawing up a PSUR - the MDCG interpretation tends to limit the lifetime to 10/15 years (after the last device has been put on the market). I am not sure if it is a good idea to generalize this interpretation to the PMS activities overall, but it might at least be a possibility to limit the efforts spent for discontinued devices.

------------------------------
Christoph Kiesselbach
Reutlingen
Germany
------------------------------

Original Message:
Sent: 15-Feb-2023 13:50
From: Carrie Krieger
Subject: EU MDR PMS After Product Discontinuation

What is the requirement for continuing PMS after a product has been discontinued from marketing and sales in the EU, but still is supported by repair activities?

------------------------------
Carrie Krieger
Director of Quality Assurance & Regulatory Affairs
Herndon VA
United States
------------------------------