Industry best practice about Post-Market Surveillance and Risk Analysis

alimary15

Involved In Discussions
Good morning,

Is there an industry best practice on how to perform post-market surveillance and mantain the Risk Management File?

I know that for ISO 14971, the Risk Management File shall be updated during all the life cycle of the device, from development untill disposal.

It is my understanding that the standard requires you to maintain the Risk Management File for "ALL PRODUCTS THAT ARE IN THE MARKET", including very old products, which might not be sold anymore by the manufacturer, but might be somewhere out there still used.

If this is the case, a big medical device company, with let?s say a product portfolio of 1000 products, is required to mantain such files for each single product type that in in the market (Eg. Software XX v.1, v.2, v.3)? or only for the products which are currently marketed (Eg. Only the latest Software version Software XX v.3) ?

Thanks!
 

Peter Selvey

Leader
Super Moderator
There are two separate obligations:

- while a device is being sold (i.e. the current version), it is required keep up to date with feedback from the market. This requires periodic review of CAPA data, incidents, literature, standards, regulatory notices etc. It is an "pro-active" system, and should be done at defined intervals. The interval might change depending on the nature of the device, risk, maturity of the technology or treatment and so on. The results should be recorded in the risk management file. The manufacturer might prepare a periodic report which covers a group of equipment if they have many similar models.

- for devices already sold, it is required to be on standby to react to incidents on the market, if necessary to trigger recall action. This is purely reactive, it can sit dormant until needed. The manufacturer must be able to assemble the information for the device in question including individual configurations (version), even if that configuration or version is no longer sold. There is however a time limit of typically 5-15 years depending on the regulation.
 

alimary15

Involved In Discussions
Thanks Peter!

Are you able to give me the reference of the requirement ? Are you taking such requirements from any standard/regulation?

Please let me know I am very curious and interested in the topic and I would like to know more!
 

alimary15

Involved In Discussions
There are two separate obligations:

- while a device is being sold (i.e. the current version), it is required keep up to date with feedback from the market. This requires periodic review of CAPA data, incidents, literature, standards, regulatory notices etc. It is an "pro-active" system, and should be done at defined intervals. The interval might change depending on the nature of the device, risk, maturity of the technology or treatment and so on. The results should be recorded in the risk management file. The manufacturer might prepare a periodic report which covers a group of equipment if they have many similar models.

- for devices already sold, it is required to be on standby to react to incidents on the market, if necessary to trigger recall action. This is purely reactive, it can sit dormant until needed. The manufacturer must be able to assemble the information for the device in question including individual configurations (version), even if that configuration or version is no longer sold. There is however a time limit of typically 5-15 years depending on the regulation.

Thanks! Could you please redirect me to the standard /regulation that is describing such practice?

Thanks again!
 

Peter Selvey

Leader
Super Moderator
Actually to be honest looking at the post again, technically it is not correct, rather it is based on reasonable assumptions and looking ahead to the final outcomes.

The more correct version is that post market information is always required but it has two different purposes: first to feed through to improvements on devices currently being sold, the second is to trigger recall.

In the first case the bar for useful post market information is fairly low. The manufacturer can periodically make small improvements to the design of the device at relatively low cost.

In contrast recall is a very high cost activity so the bar for useful feedback is equally high.

Review of clinical or scientific literature, for example, could reasonably trigger design changes, but it is rather a stretch to expect it to trigger a product recall.

For devices no longer being sold, only recall side applies. So the type of useful information will change, generally the only post market information that could trigger a recall are reported incidents for the specific model or series.
 
E

esalsan

Hi Alimary,

Please have a look at the MEDDEV guidance documents in this page (section 2.12 market surveillance; vigilance) https://www.meddev.info

recommendations issued by team-nb such as: (broken link removed)

and the documents published by the IMDRF (former GHTF): https://www.imdrf.org/documents/doc-ghtf-sg2.asp

Also note, you do not need a separate file for each device. You can, for instance, group multiple devices into a single file for a "family of devices" (that share a number of characteristics).

Hope it helps.
 
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