MDR PMS System Vs. Plan Vs. Procedures


Quite Involved in Discussions
Hi All,

Slightly confused by the expectations for the PMS plan, as required by the MDR Article 84

The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in ►C2 Section 1 of Annex III. ◄ For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.

Article 83 lays out that the PMS System shall be integral to the QMS

1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(9).

If the PMS System shall be based on the plan, and the PMS System shall be integral to the QMS surely the hierarchal structure puts the plan at the top, defining what your requirements are, the system below it with all of the relevant processes and procedures that fulfil the system requirements, then the output of those processes is the PMS Report or PSUR, and any subsequent activities in accordance with the processes/procedures, based on the conclusions.

After reviewing the detail required by the PMS Plan as per Annex III, with a few specific examples, this seems to confirm the plan as a much higher level document than a per-device document.

(b) The post-market surveillance plan shall cover at least:
— effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
— methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
— reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
— systematic procedures to identify and initiate appropriate measures including corrective actions;

These all seem like very generic requirements that should be fulfilled by integrated into procedures within a business and then applied consistently as per the risk classification of the device in question.

If all of these have to be documented in a plan, for each device, surely it's nearly all going to be standard/static text for every single plan with the only part I can see as being unique to an individual device is any justification for no PMCF requirements.

I see very little value add in this, but would really like to understand how other people have managed this?

Am I missing something fundamental here?




Trusted Information Resource
One place that I would expect this narrative to begin would be in a Risk Management Report for the medical device (or family of devices). It is common that the RMP contains:
  • The statement of risk acceptability for marketing the device
  • The links to the analyses supporting the acceptability decision
  • Plans for periodic review of risk acceptability (which ought to take inputs from the post-market surveillance system)
The periodic risk review could also include other activities not strictly related to "14971" risk, but if the review is going to include more diverse activities it will be necessary to have more diverse competencies as part of the review.

The "high level" (i.e. non-device specific) planning would likely be defining per procedure where the activities are to occur, as opposed to taking an ad hoc approach to trying to guarantee that they are done.


Quite Involved in Discussions
One place that I would expect this narrative to begin would be in a Risk Management Report for the medical device (or family of devices). It is common that the RMP contains:

That's precisely where it does begin
Currently remediating risk for a company going to MDR and as I was getting through the RMR I was trying to reference their PMS Plan, which in a previous life under MDD would have been a basic affair:

1. purpose
Gather PMS data and analyse in accordance with procedure XYZ
2. scope
Devices XYZ
3. frequency
Every X Years, based on XYZ
4. reporting
Report prepared using form XYZ

The procedure would capture everything you needed to do, what data to gather, how to analyse it and against what criteria (usually with reference to the risk process & CER process for acceptable risk, and acceptable performance, respectively)

However the documented requirements in the MDR seem like I'm going to be double documenting.


Quite Involved in Discussions
In my experience, there is definitely quite a bit of overlap between inputs for the Trend Report ( Article 88 ), PSUR, and PMCF. Just copy + paste and use the MDCG guidance format. MDCG 2020-7, MDCG 2020-8.
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