Label Translation SOP - MDD or ISO 13485 requirements?

R

Roland Cooke

#11
Here's an approach I might take in regards to this:

1. "Show me how you have complied with the requirements of Article 17, Annex II/V of the MDD, and ISO 13485 4.2.1.f. for your existing product range"

2. "Show me how changes to your existing product range will be controlled (from a documentation perspective)"

3. "Show me how additions to your existing product range will be controlled (from a documentation perspective)"


Strictly speaking a company probably DOESN'T need a procedure for #1, it just needs to show that its required documentation complies. I've got no argument there.

But when I ask to see where it says in the document control procedures that the DoC (document) will be reviewed for continued accuracy before a change (such as #2 and #3) takes place, things tend to go a little quiet.


Of course the level of control required varies an awful lot, and the possible approaches to address this control vary just as much.

I see many companies list every last eventuality, other merely say "we will follow the requirements of the Directive before we make a change / introduce a new product".

Both demonstrate intent to comply, both carry risks of non-compliance.

I would recommend somewhere in the middle, but YMMV.
 
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W

wrodnigg

#12
What about a procedure for a CE Marking, Technical File, Declaration of Conformity? Do I actually need this? Can someone show me the shall!
The files/documents or specific documented procedures for them?
You do not need a specific procedure for any of them - you need your technical file controlled and maintained (including declaration of conformity) (domcument control and/or design/development control).

CE marking is one step in manufacturing (thus hopefully included somewhere in your manufacturing procedures/specs)...

And some more words to MedDev:
They are "Guidelines" relating to medical devices Directives and they "aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process."
.
 
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