Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well. 

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan. 

Thanks in advance!

Hello Anon,

You need to buy ISO/TR 20416:2020, 'Medical devices - Post-market surveillance for manufacturers'.

Annex C provides examples of PMS plans for various types of device, including for a 'large IVD analyzer'.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

Hello Anon,

If you examine the EU MDR through the Articles and in particular Annex III the information needed as part of post market surveillance is at least provided for a basis or minimum level.  Roger provides a good suggestion also looking at the ISO standard, but keep in mind this is an international standard used for any country.  The EU MDR has specific requirements which need to be addressed like Article 88 for trending.  A word of advice too, create a PMS Plan per device or device family as the "planning" should be completed per device family as this could be different between different devices including sources of PMS data or review periods.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 12-Dec-2020 10:52
From: Roger Gray
Subject: Templates for Drafting Post-Market Surveillance Plan

Hello Anon,

You need to buy ISO/TR 20416:2020, 'Medical devices - Post-market surveillance for manufacturers'.

Annex C provides examples of PMS plans for various types of device, including for a 'large IVD analyzer'.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thanks for the recommendation Roger. I'll definitely look into it!
Original Message:
Sent: 12-Dec-2020 10:52
From: Roger Gray
Subject: Templates for Drafting Post-Market Surveillance Plan

Hello Anon,

You need to buy ISO/TR 20416:2020, 'Medical devices - Post-market surveillance for manufacturers'.

Annex C provides examples of PMS plans for various types of device, including for a 'large IVD analyzer'.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

Hi All,

Please make sure you are looking at the appropriate sections of the IVDR for this (I know MDR date of application is closer, but IVD companies won't have the familiarity since they likely have not had a certified quality management system or notified body audit in the past). There are very slight differences (particularly in the Article numbering) 

Your post-market plan should utilize the system outlined in Article 78 (this is probably the best section to look at to understand what kind of information you will need to gather and understanding what to outline in your plan and how it connects to other processes (specifically risk management).

Additional detail is required based on your IVD classification (A, B, C or D) as post-market surveillance report (PMSR) is required for Class A & B devices (Article 80) while a Period Safety Update Report (PSUR) is required for Class C and D devices under the IVDR (Article 81). Your post-market plan should be tailored accordingly. 

The advice I would provide is to read those requirements (from Articles 78-81) and then use Annex III (outlines again what your plan must cover) and you can also use ISO TR 20416 as an example (this is a pretty good document that was directly aimed at helping you meet the requirements of EU MDR/IVDR--a little self-promotion here as I was on WG6 that wrote this document). 

Keep in mind that the reason behind asking for the Post Market Surveillance process is to ensure that manufactures have all the information available to show the safety and performance of their device.

Good luck!

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

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thank you so much for your advice Mark!
Original Message:
Sent: 14-Dec-2020 09:55
From: Mark Swanson
Subject: Templates for Drafting Post-Market Surveillance Plan

Hi All,

Please make sure you are looking at the appropriate sections of the IVDR for this (I know MDR date of application is closer, but IVD companies won't have the familiarity since they likely have not had a certified quality management system or notified body audit in the past). There are very slight differences (particularly in the Article numbering)

Your post-market plan should utilize the system outlined in Article 78 (this is probably the best section to look at to understand what kind of information you will need to gather and understanding what to outline in your plan and how it connects to other processes (specifically risk management).

Additional detail is required based on your IVD classification (A, B, C or D) as post-market surveillance report (PMSR) is required for Class A & B devices (Article 80) while a Period Safety Update Report (PSUR) is required for Class C and D devices under the IVDR (Article 81). Your post-market plan should be tailored accordingly.

The advice I would provide is to read those requirements (from Articles 78-81) and then use Annex III (outlines again what your plan must cover) and you can also use ISO TR 20416 as an example (this is a pretty good document that was directly aimed at helping you meet the requirements of EU MDR/IVDR--a little self-promotion here as I was on WG6 that wrote this document).

Keep in mind that the reason behind asking for the Post Market Surveillance process is to ensure that manufactures have all the information available to show the safety and performance of their device.

Good luck!

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

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

Creating the PMS Plan template is easy; creating the plan is not.

For the template, start with Annex III(1)(b). It is a list of indents. Each one is a section of the template. You will need some preliminary information about the plan, the manufacturer, and the device. Look at MDCG 2020-7. There is a table just above Section A that you should copy into the template. In addition, you should also copy Section A and Section B into your template. Look at the rest of MDCG 2020-7 for ideas on formatting.

Take each indent from Annex III(1)(b) and make it a section heading. For example, Section C in your template becomes: A proactive and systematic process to collect any information referred to in point (a). My recommendation is that you take each item from point (a) and describe how your company collects the information. I like a table format with each item from point (a) in the left column and the method in the right column. For the plan, list your ISO 13485:2016 SOP that implements the data collection. Remember, however, that ISO 13485:2016 does not fully satisfy the QMS requirements in Article 10. You may need to write or revise your existing SOPs. See CEN/TR 17223:2016 for guidance on identifying the gaps.

Continue in this fashion through all the indents, making them separate sections in the template.

In some cases, you may want to split the indents. For example, "effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field" might be better as one section dealing with complaints and one section dealing with market-related experience.

The sample plans in ISO/TR 20416:2020 Annex C can give you some recommendations on wording, but non of the sample plans meet the requirements of Annex III. You need to develop your own template to meet all of the Annex III requirements. Then, you will need very specific information for each device or device family to complete the plan.

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

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!

Good evening,

we have shared a simple mindmap/flowchart of a PMS system here https://artpharm.hu/wp-content/uploads/2019/02/post-market-surveillance.pdf 

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 19-Dec-2020 09:45
From: Dan O'Leary
Subject: Templates for Drafting Post-Market Surveillance Plan

Creating the PMS Plan template is easy; creating the plan is not.

For the template, start with Annex III(1)(b). It is a list of indents. Each one is a section of the template. You will need some preliminary information about the plan, the manufacturer, and the device. Look at MDCG 2020-7. There is a table just above Section A that you should copy into the template. In addition, you should also copy Section A and Section B into your template. Look at the rest of MDCG 2020-7 for ideas on formatting.

Take each indent from Annex III(1)(b) and make it a section heading. For example, Section C in your template becomes: A proactive and systematic process to collect any information referred to in point (a). My recommendation is that you take each item from point (a) and describe how your company collects the information. I like a table format with each item from point (a) in the left column and the method in the right column. For the plan, list your ISO 13485:2016 SOP that implements the data collection. Remember, however, that ISO 13485:2016 does not fully satisfy the QMS requirements in Article 10. You may need to write or revise your existing SOPs. See CEN/TR 17223:2016 for guidance on identifying the gaps.

Continue in this fashion through all the indents, making them separate sections in the template.

In some cases, you may want to split the indents. For example, "effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field" might be better as one section dealing with complaints and one section dealing with market-related experience.

The sample plans in ISO/TR 20416:2020 Annex C can give you some recommendations on wording, but non of the sample plans meet the requirements of Annex III. You need to develop your own template to meet all of the Annex III requirements. Then, you will need very specific information for each device or device family to complete the plan.

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

Original Message:
Sent: 11-Dec-2020 12:56
From: Anonymous Member
Subject: Templates for Drafting Post-Market Surveillance Plan

This message was posted by a user wishing to remain anonymous

Hello Everyone,

Hope all is well.

We at our company are drafting a new Post-Market Surveillance Plan for our IVD medical devices in accordance with the IVDR Regulations. I'm fairly new to this area and have not worked much on Post-Market Surveillance activities for IVDs. I was looking for some guidance in terms of getting any reference templates or guidance document recommendations from this platform which could help me in drafting the PMS Plan.

Thanks in advance!