Advisory Notice Requirements & Procedure and Form examples

[Amanda B.]

Hi all,

I need to incorporate an advisory notice procedure into our existing QPM - we currently state that we will issue an advisory notice if it becomes necessary but there are no details on the process ...I understand the definition of the advisory notice and (I think) when it should be performed, but what I'm trying to find out is if there are any particular requirements (or suggestions from brilliant minds on the forum ) for what that advisory notice form should like and what the procedure should entail?

FYI: I started looking because we have kits in a distributors warehouse which currently hold items that we (the manufacturer) would like to pull out of the kit. From what I can tell an advisory notice is warranted here - there is no danger from the item, the test will perform to specs without the item and the item has been historically offered as a complement to the test....but we want to discontinue that practice. In order to effect the change for kits currently in the distributors warehouse, from what I can tell under 3.3 "modification of a medical device' an advisory notice would be the way to go.
Am I on the right track here? :-)~ And if yes, does anyone have any suggestions on the procedure and/or form?

Thanks so much!

Amanda

[Amanda B.]

Do I stink? Did I say something wrong?
Is there anyone who can point me in the right direction on my post? Please?
I'm desparate here, my boss says, "So, what have you found out?" Me..."ummmm...." LOL.
And btw, as a newbie here I have another question..I've only posted a couple of times..and I've thanked people via message, but apparently that doesn't 'count' because my profile says I haven't thanked anyone, which makes me feel terribly rude. How does one thank someone 'officially' on the forum?

Thanks!!

Amanda

[GStough]

In Reply to Parent Post by Amanda B.

Hi all,

I need to incorporate an advisory notice procedure into our existing QPM - we currently state that we will issue an advisory notice if it becomes necessary but there are no details on the process ...I understand the definition of the advisory notice and (I think) when it should be performed, but what I'm trying to find out is if there are any particular requirements (or suggestions from brilliant minds on the forum ) for what that advisory notice form should like and what the procedure should entail?

FYI: I started looking because we have kits in a distributors warehouse which currently hold items that we (the manufacturer) would like to pull out of the kit. From what I can tell an advisory notice is warranted here - there is no danger from the item, the test will perform to specs without the item and the item has been historically offered as a complement to the test....but we want to discontinue that practice. In order to effect the change for kits currently in the distributors warehouse, from what I can tell under 3.3 "modification of a medical device' an advisory notice would be the way to go.
Am I on the right track here? :-)~ And if yes, does anyone have any suggestions on the procedure and/or form?

Thanks so much!

Amanda

Hi Amanda,

This is not exactly my area of expertise, but I will attempt to help. Perhaps some of the more knowledgeable Covers in this subject will jump in to help shortly.

You didn't mention whether your company is registered to ISO 13485, but I'm assuming that you are. The standard (8.5.1) just states "The organization shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time." It leaves the "how" and "when" up to the organization so that you can fit it to your company's and customer's needs, requirements, etc.

As for a specific format, again that is left up to your organization to determine whatever will work best for you. If you haven't already done so, I'd like to suggest that you take a look at the Post Attachments List (the thin green bar at the top of this page) and see if there may be a template posted that you could use for a guide as you develop this form and/or procedure. There are many, many great documents, templates, etc. posted there and hopefully, you can find something useful for your needs or at least to provide a good foundation.

I hope this helps.

[ScottK]

Hi Amanda.

not sure If I'll be much but I'll give it a shot...
As I understand advisory notices they are used to notify customers with supplementary information on an item already delivered. You say they're at a distributor so I'm not sure if that's the definition of delivered or not - I kind of consider delivered to be at the end user.
You want the distributor to remove an item from the kit. Will you need to also send out updated user instructions or carton labeling to show the new contents?

Depending on the quantity at the distributor this might be better to either send replacement kits with the current components and have distributors return the outdated ones OR grandfather the outdated ones and only send the current ones from now on.
I know if I was a distributor of a kit I wouldn't want the responsibility and potential problems of opening the kits and modifying them. I'd want to send them back to you and have you do it.

Either way I supppose a notifictation is called for... I would just write a letter, on company letterhead of course, describing the situation and how you plan to resolve it. If you want to make a formal form, by all means do, but I don't believe it's required unless your procedure calls for it.

I hope that helps a little... I've been out of hard medical devices for a while so I may be rusty.
-------------------------------

As fars as thanks, there's three things you can do:
1) click the "thanks" button at the bottom of a post - this adds to counts
2) Click the little yin-yang button at the top of the post to "add karma" and leave a comment.
3) send a PM as you have done.

[chris1price]

Hi

As a start, I would suggest reading the Meddev 2.12/1 vigilance guidlines at http://ec.europa.eu/enterprise/medical_devices/meddev/ or the GHTF SG2 documents at http://www.ghtf.org/sg2/sg2-final.html

If you are in the UK, the MHRA guidelines, Bulletin 3 at http://www.mhra.gov.uk/home/idcplg?I...AGE&nodeId=369 might be useful. The MHRA are also holding a conference next week on their vigilance procedures.

Hope this helps.