First Monica, you are definitely on the right path with some good topics raised when it comes to PMS and PMS Plans, you are raising issues that are not just within your company, but interpretation across the industry.
The next point is that CAMD have stated they are developing a guidance document on Post Market Surveillance (PMS) management which includes PMS Plans. There were some statements in public conferences that possibly there would be some templates or structures for what PMS Plan would look like or should contain. As can be imagined, like most regulatory tools, templates, documents, etc., these are developed through industry and there is not necessarily only one right way to do it.
I could further comment that you should keep an eye out for ISO TR 20416 which is titled Medical Device - Post Market Surveillance for Manufacturers. Note that this is
not yet published - this is being generated by TC 210 the same Technical Committee responsible for ISO 13485. So also note this is coming from ISO 13485 perspective and not MDR (EU) 2017/745.
Boiling down an almost full day of training on EU MDR specifically for PMS - I can give you some of my thoughts and ideas. In discussion with different people, as you have well seen Monica even within your own group, there are differing opinions on what this whole PMS documentation should look like.
- A PMS Plan can or can not be a standard operating procedure. I had feedback from some auditors that they believe a PMS Plan should not be a SOP. A PMS Plan should be a stand-alone document. (There could be a SOP describing how to make a PMS Plan such as a WI telling exactly how to put this together, including a template.)
- Yes, agree that there can be a "PMS Plan template" that is then completed for each product family, see note below.
- There must be a SOP for management of the overall PMS system, such as data sources, review periods, what to do with data, where data gets reported, what causes a corrective action, etc.
- Depending on how many product lines or product families, there could be 1 or more PMS Plans, i.e. if a company has say 3 Product Family with say 4 models/versions in each product family, there would be 3 PMS Plans.
- PMS Plan is a living document, it should be in document control, should have a version level, can be revised, can change, as things with the product changes, risk management, clinical evidence, etc.
- PMS Plan should not be done in isolation, this is a cross-functional activity from regulatory, clinical, engineering, design, manufacturing, marketing, sales, etc (could be created by one person, but should be reviewed by a team).
- PMS Plan(s) and PMS is part of Technical Documentation (Annex III) so needs to be structured accordingly.
Not an all inclusive list, and just my initial thoughts and interpretations on PMS Plans. It would be really interesting to hear other peoples thoughts on this topic as well because talking with people I do get differing opinions.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Sep-2018 06:51
From: Sandra Bausback Aballo
Subject: EU MDR PMS Plan
Hi Monica,
I can tell you that my company follows the thought process in your second bullet below:
Others believe that the PMP Plan is a collaborative efforts between several areas knowledgeable of the device characteristics, risks, usability and design. This becomes a shell that is sent through document control and it's saved as part of the product's technical documentation file.
One team is considered the "owner" of the document but it is a collaborative effort with RA and Clinical as well as the Vigilance team. Our plans follow the same template, but are tailored for each individual device- some are supported by post-market clinical studies, others are supported through IIS and publications. Our PMS plan does route through document control.
As far as SOPs- we have an overall PMS System SOP, which currently references the PMS plan. Our goal is to develop a separate SOP for the PMS plan, and formalize the template.
Let me see what I can do as far as finding you a shell template you can use.
Sandi
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Sandra Bausback Aballo
NJ
USA
Original Message:
Sent: 27-Sep-2018 20:29
From: Monica Lozano
Subject: EU MDR PMS Plan
Hello Colleagues,
I am a Medical Device consultant working on a project updating SOPs to comply with the new EU MDR. Right now we are focusing on PMS, unfortunately this manufacturer does not have a PMS System in place. Aside from working on creating new SOPs for PMS, we are making sure that we cover the EU MDR requirements.
I have been looking for information or samples for PMS Plans or PMS Plan Templates, and I have not had any luck. It was decided that we need a PMS Plan SOP, and we have come to a fork on the road, on a few issues regarding to the PMS Plan.
1- PMS Plan SOP or Template
- Some people believe that the PMS Plan is created by one person in the PMS unit using a step by step WI .
- Others believe that the PMP Plan is a collaborative efforts between several areas knowledgeable of the device characteristics, risks, usability and design. This becomes a shell that is sent through document control and it's saved as part of the product's technical documentation file.
2- The second issue is the role that the PMS Plan plays.
- Some people believe that the PMS Template is used as guide to create the PMS Plan for each product. This plan becomes a shell that is sent through document control and it's saved as part of the product's technical documentation file. Then the individual product PMS Plans gives direction and is used as a vessel as far as the collection, analysis and conclusion of reports.
- Other people think that the PMS Plan is created every single time that PMS data or reports are require.
I truly believe that we are making this more difficult than it is.
Can anyone supply me with more details, or SOP samples or PMS Plan sample or any information that might clarify any of these issues?
I appreciate for taking the time to read this.
Thanks
Monica Lozano
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Monica Lozano
Rocky Hill CT
United States
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