ISO 13485:2016 and regulatory requirements - Contract Manufacturing

G

gmaltby

#11
Ah well no supply agreements I have signed contain any 'defined' regulatory requirements (i.e. 93/42/EEC) but they do sometimes state (for example) item x should be 4.0+/-0.3mm x 7.0+/-0.3mm is that where you are coming from?

So essentially if i cover the relevant clauses with 'where applicable' we will be covered?
 
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Marcelo

Inactive Registered Visitor
#12
As I mentioned, the fact that it has never been done does not mean that it's not necessary. Unfortunately, this distinction of a third party and a supplier is not very well understood.

I don't see an easy solution for your problem. Maybe you should keep as you done and wait for an y comments from the certification body.

Most will accept anything without too much thought, unfortunately.
 

shimonv

Trusted Information Resource
#13
Excuse me for cutting in...

Based on what gmaltby wrote earlier it seems that they are a supplier of custom tubes, not a contract manufacturer for a finished device.
If this is correct, then "N/A we are a component manufacturer" is a good answer.

...We have no idea in most cases what this tubing is even used for so cannot comply to regulatory requirements as we do not know what they would be.
 

Marcelo

Inactive Registered Visitor
#14
Excuse me for cutting in...

Based on what gmaltby wrote earlier it seems that they are a supplier of custom tubes, not a contract manufacturer for a finished device.
If this is correct, then "N/A we are a component manufacturer" is a good answer.

Even if so (and please bear in mind that the third party clause is not for finished devices only, so it could apply to them), there's no option in ISO 13485 to apply non-applicability to clauses different than Clause 6,7 and 8. There's several things related to regulation in clause 4 and 5, and there's no way to put them as NA.
 
G

gmaltby

#15
So what about clause 5.6.2c and 7.2.3c how can we report/communicate to regulatory authorities surely this can be N/A?
 

Marcelo

Inactive Registered Visitor
#16
So what about clause 5.6.2c and 7.2.3c how can we report/communicate to regulatory authorities surely this can be N/A?
For item 7, you can have NAs if you don't perform the activity.

But ISO 134845 does not have an option to include NAs for clause 5. In fact, there are several instances in clause 5 (for example, the medical device file), which would be NA for different organizations, however, the standard do not have that option (this is one of the problem related to the expanded scope, the group did not check everything that could be NA in clauses 4 and 5), or, better yet, the group did notice some, but it was too late in the development cycle to change).
 

Roland chung

Trusted Information Resource
#17
For item 7, you can have NAs if you don't perform the activity.

But ISO 134845 does not have an option to include NAs for clause 5. In fact, there are several instances in clause 5 (for example, the medical device file), which would be NA for different organizations, however, the standard do not have that option (this is one of the problem related to the expanded scope, the group did not check everything that could be NA in clauses 4 and 5), or, better yet, the group did notice some, but it was too late in the development cycle to change).
So, what is the solution? It is not the responsibility of contract manufacturer to report the events to regulatory authorities.
 
G

gmaltby

#18
A contract manufacturer would have to report to regulatory as they would know what the product they produced was used for or in. We do not. We have no idea even if our customers are using it in a medical device and if they are which countries they are selling that device to. So how can we report to regulatory authorities when we don't even know who that authority would be????
 

Marcelo

Inactive Registered Visitor
#19
So, what is the solution? It is not the responsibility of contract manufacturer to report the events to regulatory authorities.
I don't think there's a solution in the current text of ISO 13485, unfortunately.

A contract manufacturer would have to report to regulatory as they would know what the product they produced was used for or in. We do not. We have no idea even if our customers are using it in a medical device and if they are which countries they are selling that device to. So how can we report to regulatory authorities when we don't even know who that authority would be????
As I mentioned before, maybe you should keep as you done and wait for any comments from the certification body.
 

sandra2014

Involved In Discussions
#20
Hello, we are a contract manufacturer of cables, wire harness, and mechanical box build. We recently completed our Upgrade certification audit to ISO 13485:2016 with one minor finding. A recommendation was going to be be added to our audit report, but was successfully challenged, the 3rd party auditor wanted us to update our statement of scope from turnkey Cable, Harness and Mechanical Assemblies for Medical Device Industries to include: non implantable or implantable medical devices. We do not know what the product end use is for, and the lead auditor agreed with us stating that we only build components for our clients so, this recommendation does not apply to us. Is this correct?:confused:
 
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