Post Market Surveillance Guidelines or examples of procedures

E

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!:eek:

Thank you,
Emily
 

J0anne

Joanne
Re: Post Market Surveillance

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

Fully vaccinated are you?
Leader
Re: Post Market Surveillance

<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

Leader
Admin
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!:eek:

Thank you,
Emily

Hi Emily,

Welcome to the Cove :bigwave:

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 :)
 
Last edited:

Sam Lazzara

Trusted Information Resource
Here are some resources.

Path to Notified Body public documents:

www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=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
 

Attachments

  • EU NB-MED_2.12_Rec1_Rev 11_Post-Marketing Surveillance - PMS.pdf
    111 KB · Views: 1,569
  • EU MEDDEV 2.12-2_May 2004_Guidelines on Post Market Clinical Follow-Up.pdf
    78 KB · Views: 757
  • GHTF Review of Current Requirements on Postmarket Surveillance 2005_sg2-n47r4.pdf
    183 KB · Views: 879
  • GHTF Proposed SG5_PD_N4R7 Post Market Clinical Follow Up Studies_2009.pdf
    87.1 KB · Views: 755
Last edited by a moderator:
T

tec11

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

zolakeene

Hi Guys

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

Haresh

Involved In Discussions
Dear Team,
I have one query is that suppose the manufacturer produces semi-finished component say example- Medical tubing, does the manufacturer requires PMS sop ?
Awaiting your response.
 

Sam Lazzara

Trusted Information Resource
PMS requirements, in all jurisdictions I have seen, only apply to finished medical devices.
Components are not finished devices. I would avoid calling them "semi-finished" since that can cause confusion.
 
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