Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

Registries and databases are just a few tools you can use for PMCF. Depending on the device you may collect used devices after their disposal, just to see their wear and tear, you may talk with patients or other users, you may look at social media platforms where patients may share experiences with all sorts of intervention including your device, etc. Your research questions may also cover a wide field, also depending on the nature of your device: questions related to quality of life, usability, side-effects, etc. 
PMCF should not be seen as a check-box operation. It should have clear research questions and a well thought-out strategy to answer them. I offer training in PMS/PMCF where I dive deeper into these aspects. 

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

Hello Anon,

Post Market Clinical Follow-up (PMCF) may or may not be required - this depends if you have sufficient clinical evidence to support a legacy device or product which has been on the market for a number a years.  There is a lot of mis-understanding and interpretation around PMCF so you will see significant variation between Notified Bodies and even between reviewers within the same Notified Body.  Unfortunately they take the approach PMCF is always required unless justified instead of an approach that PMCF is not required unless there is no sufficient clinical evidence.  Also there is a lot of confusion between PMCF and PMS.

Because there is such variations with Notified Bodies, personally would recommend having this discussion with your Notified Body specific to your device.  This can also depend highly on your device type.  If you are looking at conducting PMCF, make sure to look at the MDCG guidance templates which provides some insight into what PMCF methods would be for a device.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Apr-2023 03:19
From: Ronald Boumans
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

Registries and databases are just a few tools you can use for PMCF. Depending on the device you may collect used devices after their disposal, just to see their wear and tear, you may talk with patients or other users, you may look at social media platforms where patients may share experiences with all sorts of intervention including your device, etc. Your research questions may also cover a wide field, also depending on the nature of your device: questions related to quality of life, usability, side-effects, etc.
PMCF should not be seen as a check-box operation. It should have clear research questions and a well thought-out strategy to answer them. I offer training in PMS/PMCF where I dive deeper into these aspects. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

I think the items behind your questions are a big part of the reasons that PMCF was inserted into the EU MDR. How is it that we don't have the contacts (can get feedback) on the clinical use of our products. Shouldn't we be proactively asking our users (clinicians) for feedback on the use of our products? This is NOT the same as a clinical study or even a post market registry. PLEASE go ask the doctors, nurses and other clinicians (even ask patients if appropriate) about the performance of your products. Are you afraid of what you might hear?? If that is the case, you probably need to hear all that much more. Good luck!

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

Original Message:
Sent: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

In situations where the PMCF database/registry/CRO for conducting PMCF activities is not ready or available for legacy medical devices, there are still options to demonstrate compliance with the requirements of the EU Medical Device Regulation (MDR) 2017/745. Here are some alternative approaches:

Post-Market Surveillance (PMS) and Complaints Data: Utilize the available PMS and complaints data to demonstrate ongoing monitoring of device performance and safety. Analyze and evaluate this data to identify any trends, potential risks, or issues associated with the device. Document the analysis and any actions taken based on the findings.

Literature Review: Conduct a thorough review of relevant scientific literature, clinical studies, post-market publications, and other published data related to similar devices or technologies. This helps to gather information on device performance, safety, and any potential updates or changes in the state of the art.

Clinical Evaluation Report (CER): Prepare or update the CER for the legacy device according to the requirements of the EU MDR. The CER should include a comprehensive review of all available clinical data, including clinical investigations, real-world data, and post-market surveillance information. Emphasize the importance of the available PMS and complaints data in demonstrating ongoing device safety and performance monitoring.

Risk Management: Review and update the Risk Management File (RMF) for the legacy device. Assess the potential risks associated with the device and evaluate the effectiveness of existing risk control measures. Incorporate any relevant information from PMS, complaints, and literature review to address potential risks and ensure ongoing risk management.

Periodic Safety Update Reports (PSURs): Prepare and submit PSURs as required by the EU MDR. PSURs provide a comprehensive summary of the safety and performance data for the device, including updates on adverse events, complaints, and other relevant information. Ensure that the available PMS data and complaints information are appropriately included in the PSURs.

It is important to document and justify the chosen approaches in demonstrating compliance with the EU MDR for legacy devices. Keep comprehensive records of the alternative strategies implemented and the rationale behind them. During audits or inspections, provide a clear and transparent explanation of the steps taken to fulfill the requirements despite the unavailability of a PMCF plan/report.
------------------------------
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: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

Raje Devanathan - I believe the items you listed are all required under
the regulations and simply will not satisfy the PMCF requirements.


Original Message:
Sent: 5/16/2023 2:14:00 PM
From: Rajeswari Devanathan
Subject: RE: Details for the performing compliant PMCF acc. EU MDR 2017/745

In situations where the PMCF database/registry/CRO for conducting PMCF activities is not ready or available for legacy medical devices, there are still options to demonstrate compliance with the requirements of the EU Medical Device Regulation (MDR) 2017/745. Here are some alternative approaches:

Post-Market Surveillance (PMS) and Complaints Data: Utilize the available PMS and complaints data to demonstrate ongoing monitoring of device performance and safety. Analyze and evaluate this data to identify any trends, potential risks, or issues associated with the device. Document the analysis and any actions taken based on the findings.

Literature Review: Conduct a thorough review of relevant scientific literature, clinical studies, post-market publications, and other published data related to similar devices or technologies. This helps to gather information on device performance, safety, and any potential updates or changes in the state of the art.

Clinical Evaluation Report (CER): Prepare or update the CER for the legacy device according to the requirements of the EU MDR. The CER should include a comprehensive review of all available clinical data, including clinical investigations, real-world data, and post-market surveillance information. Emphasize the importance of the available PMS and complaints data in demonstrating ongoing device safety and performance monitoring.

Risk Management: Review and update the Risk Management File (RMF) for the legacy device. Assess the potential risks associated with the device and evaluate the effectiveness of existing risk control measures. Incorporate any relevant information from PMS, complaints, and literature review to address potential risks and ensure ongoing risk management.

Periodic Safety Update Reports (PSURs): Prepare and submit PSURs as required by the EU MDR. PSURs provide a comprehensive summary of the safety and performance data for the device, including updates on adverse events, complaints, and other relevant information. Ensure that the available PMS data and complaints information are appropriately included in the PSURs.

It is important to document and justify the chosen approaches in demonstrating compliance with the EU MDR for legacy devices. Keep comprehensive records of the alternative strategies implemented and the rationale behind them. During audits or inspections, provide a clear and transparent explanation of the steps taken to fulfill the requirements despite the unavailability of a PMCF plan/report.
------------------------------
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: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!

Hi,

If its just to comply with the requirement to perform PMCF and avoid discussions surrounding a rationale that no PMCF is required, the minimum you can do is to plan for literature reviews. Literature reviews are mentioned in the MDR Annex XIV part B as an example of a general PMCF method. You will be doing such literature reviews for your clinical evaluation anyway. By listing them as a PMCF activity you check the box of having a PMCF plan.

However, the real intent of the MDR is not for us to check boxes but to thoroughly understand and monitor the safety and performance profile of our devices. I could not agree more with what Mark Swanson wrote earlier. If you sit together with R&D, clinical and regulatory and really talk about what you know and do not know about the safety and performance of your device, there will usually be questions that are suitable to address with some proactive activity. There is always room for your body of data to grow. Do what is reasonably possible. We are not going to perform post-market trials on simple commodity devices. But we can be creative in how we collect data from the clinical use of the devices: surveys, registries, customer feedback, a collection of structured notes from observing procedures with the device, etc.

Good luck!

------------------------------
Wiebe Postma
Vierpolders
Netherlands
------------------------------

Original Message:
Sent: 28-Apr-2023 02:16
From: Anonymous Member
Subject: Details for the performing compliant PMCF acc. EU MDR 2017/745

This message was posted by a user wishing to remain anonymous

What are the real options for legacy medical devices to demonstrate current compliance with the requirements of the EU MDR 2017/745, in case PMCF database/registry/CRO to perform PMCFs are not ready / not available? PMS and complaints data are available but no ongoing PMCF activity in terms of PMCF plan/report. How do you demonstrate EU MDR 2017/745 in these situations for these legacy devices in audits/inspections without PMCF plan/report ready and available ? Thank you!