Advisory Notices - Who is responsible for dealing with Advisory Notices?

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#1
From an email I received:

Dear mark smith
I request you to place this question in correct thread

WE work as a contract manufacturer that is certified for ISO13485, and builds several different semi finished finished medical devices and sub assembly for medical devices . I am still confused about Advisory Notices.
Would our customers (i.e., the corporations marketing the devices) be responsible for dealing with them?
we will be going ahead with adding ISO 13485:2003 by dec of 2006. ISO ,
I hope you some one has closed the requirements with refernce to risk analysis procedure and advisory notices

request the help and guidelines to develop them .

Regards
Gprasadhc
 
Elsmar Forum Sponsor
J

jrubio

#2
Dear Marc, I will try...

This is a legal concept of responsability of product. Civil + Administrative + penal responsability

In Europe.
Always the manufacturer of the dangerous or medical finished product. or the legal person (Case of Outside of Europe producer) in charge who trade the product in Europe.

In medical scenarios -> The finished builder or the legal representative. Only one responsibility.

For machines. The finished builder as final constructor who must see the interact of all Safety elements and subsidiary one sub-assemblers of sub-assemblies of Secury parts, in case of not provided critical and safety info regarding their product to the final builder

i.e Elevators.

The producer (In Europe is the installer according to Directive of Elevators) of the Elevator has the responsibility to put final advisory noticed, but for every part of the Elevators (Safety parts, i.e Chain must have also it C.E mark and advisory legend).

To summarise:

The final builder who put the product in the market under their responsibility and brand.

Civil + Administrative + penal responsability..
:bonk:


In your case you must supply to your Customer all the Risk analysis of your subassembly in order they will bear in mind the interaction of all parts (Manual instruction of how to install and maintained your sub-assembly , but it is Their responsibility not yours the final advisory noticed. In case of chemical product you must supply the Safety card or the chemical. i.e: H2SO4 Sulfuric Acid to your Customer or just inform them.

:argue:
 
Last edited by a moderator:

Ajit Basrur

Staff member
Admin
#3
If the customer is placing the device in the market, they are responsible for "Advisory Notices". But in turn, they can request you to carry out some investigation.

Thus in your procedure, you should clearly mention about this.
 

DannyK

Trusted Information Resource
#4
The ultimate responsibility for advisory notices is with the legal manufacturer (name on medical device)

As a subcontractor, you should have a procedure that deals with this situation. In the procedure you will will describe the methods of communication and will mention that your company will contact the client, who is responsible for the medical device product.

ISO 14969 has some excellent guidelines in paragraph 8.5.1.3

Danny
 
G

gprasadhc

#5
Dear Javier Rubio and Danny

Thanks for your input
As a subcontractor, as Sub contractor we have very limited access to field issues . All our communication will be with our customer ( who is responsible for the medical device. Design ,product safety Labeling .Installation and servicing is not our responsibility )
In this case How do I exclude this class in the manual . Or what I need to write in that clause

Request some one to help me in"Risk analysis procedure" development for a subcontractor , who is Not responsible Product Design ,product safety Labeling .Installation and servicing is not our responsibility

Regards
Gprasadhc
 
J

jrubio

#6
If the design is not yours, your Company may decline a part of responsibility of the product but you are the manufacturer and you have in fact Legal responsibility for the product you produce.

Ask your customer how your product must be to be secure for them and ask them to provide you all this info, whether not create a manual of instructions ,use, purpouse of application and bad uses, installation, maintenance of your product to maintain the characteristic your Customer require and possible bad use of your product and way to avoid, even in the design, you can collaborate with your Customer as Manufacturer due to you may know all the possible problems with your product due to a bad Quality or Use of the product (Always thinking in protecting: Human, Equipments, Enviromental).

Be specific in the manual and in the Purchase Order and PPAP . that you produce the part according with the design of your Customer and try to decline responsibility in fact in the same Purchase Order stating that you assegurate that the product is under the Characteristics your Customer requires. But Always as Manufacturer you have legal responsability and by this try to close with the info I provided before all this matters,
 
Last edited by a moderator:

RCW

Quite Involved in Discussions
#7
As a medical device subcontractor, I was considering having my company put a clause in our Request For Quote documentation saying the customer (the owner of the device, whose name is on it) is responsible for issuing advisory notices to the end user.

Does anybody else do this? Is this a good idea or is it overkill?

I realize this does not release from the responsibility of notifying the customer if we run across an adverse situation BUT it does explicitly state that we are free from issuing advisory notices.
 

Al Rosen

Staff member
Super Moderator
#8
You should advise your customer and your customer has the responsibility of notifying the medical device user. If I'm a medical device mfr, there is no way that I would want my subcontractor notifying my customers.
 
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