Post Market Surveillance Guidelines or examples of procedures

[EmbTech]

I am in the search of some info and guidelines for Post Market Serveillance. I am wondering if I need to have a specific procedure on a plan for PMS. Any guidelines or examples of procedures would be very helpfull!

Thank you,
Emily

[J0anne]

I've sent you a link to the relevant info for the US.

There are other specific requirements you need for other countries.

Where are you selling?

[Marc]

In Reply to Parent Post by J0anne

<snip> I've sent you a link to the relevant info for the US. <snip>

If you put the link in a post like this: site (dot) com we'll make it into an active link. After your 5th post you will be able to post links in posts. I apologise for the inconvenience. It's a spam prevention method we use here.

[Ajit Basrur]

In Reply to Parent Post by EmbTech

I am in the search of some info and guidelines for Post Market Serveillance. I am wondering if I need to have a specific procedure on a plan for PMS. Any guidelines or examples of procedures would be very helpfull!

Thank you,
Emily

Hi Emily,

Welcome to the Cove

Since you are in the US, I provide you the links of FDA -

522 Postmarket Surveillance Studies – Frequently Asked Questions (FAQs)

Postmarket Surveillance Under 522 of the Federal Food, Drug and Cosmetic Act

21 CFR Part 822

Hope this will be helpful for you - pl come back if you have more questions

[Sam Lazzara]

Here are some resources.

Path to Notified Body public documents:

http://www.team-nb.org/index.php?opt...d=17&Itemid=38

The attached GHTF documents are more current than the attached MEDDEV documents.

From the European perspective, it is very clear that PMCFU is a subset of Post Market Surveillance. The latest European Medical Device Directives (MDD Annex X for example) mentions that if you are not planning to do PMCFU it must be "duly justified" whereas there is no getting out of doing Post Market Surveillance if you are following MDD Annex II (Full QA System) approach. MDD Annex X says:

The clinical evaluation and its documentation must be actively updated
with data obtained from the post-market surveillance. Where post-market
clinical follow-up as part of the post-market surveillance plan for the
device is not deemed necessary, this must be duly justified and documented.

Hope this helps.
Sam Lazzara

[Ajit Basrur]

Thanks Sam - this info is very useful !

[tec11]

Thanks Ajith - these links asnwered several of my questions regarding PMS for med devices.

[zolakeene]

Hi Guys

I need to distribute a PMS document would anyone have a PMS formet?