Procedures for Complaint Handling and Post Market Surveillance

bolesen

Starting to get Involved
#1
We are in the process of going though our MDD Expansion Audit and recently went through a Gap Audit.
One of the non-comformities identified was creating a Post Market Surveillance plan to submit with Technical files.

My question is in regards to a procedure covering Post Market Surveillance. We currently have a SOP Complaint Handling and Medical Device Reporting which covers most of the post production processes.

Do most of you have separate procedures(SOP) for Post Market Surveillance and Complaint Handling and Medical Device Reporting?
Or would it be better to just have one SOP and add PMS processes/content to our existing SOP Complaint Handling and Medical Device Reporting?
 
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Jen

Starting to get Involved
#2
We have separate SOP for Post Market Surveillance and Complaint Handling and Medical Device Reporting. I think it is a little difficult to combine all those procedures as they are addressing different needs.
 

mihzago

Trusted Information Resource
#3
Depends on the type, size and complexity of your company and product.
I have them combined because they address similar needs, that is monitoring and collecting data from various sources to determine what immediate (e.g. investigation, reporting, recall, etc.) or long term (e.g. trending) the company must undertake.
I keep the procedures relatively simple and lightweight and managed by a single individual, but if you work at a company that has different individuals or departments handling various aspects of the PMS, then it probably makes sense to have them separate.

Separating procedures and activities and assigning responsibilities to different departments often leads to silos, and the whole idea behind PMS is to analyze and act on the data collectively.
 

yodon

Staff member
Super Moderator
#4
I have to agree with @Jen on this one. I initially tried to go down the single SOP path but there's just so much going on in postmarket (and getting worse with MDR) it seemed to make the most sense to separate. But, if it works for you...
 

bolesen

Starting to get Involved
#5
Depends on the type, size and complexity of your company and product.
I have them combined because they address similar needs, that is monitoring and collecting data from various sources to determine what immediate (e.g. investigation, reporting, recall, etc.) or long term (e.g. trending) the company must undertake.
I keep the procedures relatively simple and lightweight and managed by a single individual, but if you work at a company that has different individuals or departments handling various aspects of the PMS, then it probably makes sense to have them separate.

Separating procedures and activities and assigning responsibilities to different departments often leads to silos, and the whole idea behind PMS is to analyze and act on the data collectively.
Thanks for your response. I am new to QMS and learning on the fly:)
We are a low risk Class IIa PACS (Imaging Software). Which I also manage our QMS individually and agree with you in keeping procedures simple and lightweight. I was just a little concerned with combining with all the post-market stuff coming with MDR as yodon mentions.
Just out of curiosity what do you name your procedure?
And anyway you could provide me an example of the procedure?
Appreciate all feedback.
 
#6
Hi Bolesen,

I can tell you what I've done for my company's post market system during the MDR transition:

Create a parent SOP for Post Market Surveillance. High level SOP that links out to child procedures, like Complaint Management, Adverse Event Reporting, Vigilance (Recalls, FSCAs, FCOs), PMCF, Post Market Surveillance Plans, PSUR prep, etc.

Additionally, for each device, a Post Market Surveillance Plan will need to be created. I cannot stress this enough, your Post Market Surveillance Procedure does NOT satisfy the EU MDR requirement of having a Post Market Surveillance Plan.

Annex III, Section 1.1 of the EU MDR:
The post-market surveillance plan drawn up in accordance with Article 84. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
(a) The post-market surveillance plan shall address the collection and utilization of available information, in particular:
— information concerning serious incidents, including information from PSURs, and field safety corrective actions;
— records referring to non-serious incidents and data on any undesirable side-effects;
— information from trend reporting;
— relevant specialist or technical literature, databases and/or registers;
— information, including feedbacks and complaints, provided by users, distributors and importers; and
— publicly available information about similar medical devices.
(b) The post-market surveillance plan shall cover at least:
— a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
— effective and appropriate methods and processes to assess the collected data;
— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- risk analysis and of the risk management as referred to in Section 3 of Annex I;
— effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; — methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
— 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;
— effective tools to trace and identify devices for which corrective actions might be necessary; and
— a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
 

Weeder

Involved In Discussions
#8
Thanks for your response. I am new to QMS and learning on the fly:)
We are a low risk Class IIa PACS (Imaging Software). Which I also manage our QMS individually and agree with you in keeping procedures simple and lightweight. I was just a little concerned with combining with all the post-market stuff coming with MDR as yodon mentions.
Just out of curiosity what do you name your procedure?
And anyway you could provide me an example of the procedure?
Appreciate all feedback.
It is best to keep the procedure separate as it makes it much more manageable. It is also easier for the auditor to examine. The new PMS has an quite an extensive set or requirements and it would be a challenge to manage them in one SOP.
 
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