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Do we need a Labelling SOP for ISO 13485?

L

louguy

#1
Hi there,
Firstly thank you to all the posters on this site, you have all been very helpful!

A little about us and our device... We are a small company with a product that we will be selling worldwide. It is a Class I medical device (in Europe, and Class II in the US)

We are CE marked and operating out of Europe.

We have created labelling documents in order to obtain our CE mark as well as the FDA has approved our Labelling section for our 510(k) application.

My questions is, do we need to create an SOP for labelling now as we move toward obtaining our ISO 13485 certification?

If so, does anyone have a template I could follow?
Many thanks in advance for your input!

Cheers,

L
 
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yodon

Staff member
Super Moderator
#2
Irrespective of whether you have to have one or not, I think you'll probably find you need one! The standard says:

7.5.1.1 General requirements
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
...
the implementation of defined operations for labeling and packaging.

So you pretty much need to define HOW you will CONTROL those operations. This gets more complicated if you have, for example, pre-printed serialized labels but the idea is, I believe, labeling needs to be tightly controlled to, of course, prevent mixups, but also to reduce the risk of counterfeits (or be able to readily identify such).
 

somashekar

Staff member
Super Moderator
#3
We have created labelling documents in order to obtain our CE mark as well as the FDA has approved our Labelling section for our 510(k) application.

My questions is, do we need to create an SOP for labelling now as we move toward obtaining our ISO 13485 certification?
Dear L
Is not your labeling documents the SOP for labelling ~~~
 

Chrisx

Involved In Discussions
#4
Since you mention FDA, you therefore need a labelling procedure to comply wit 21CFR820.120 "Each manufacturer shall establish and maintain procedures to control labelling activities".
 
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