Device Master Record Requirements for Component Manufacturer

I

ISODOC

#1
We recently had an ISO 13485 audit and was issued a non-conformance for not having a DMR. Do you need to have a DMR if you are only producing a component consisting of only one item?

Any help would be appreciated.
 
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GStough

Staff member
Super Moderator
#3
:bonk:
Does the terminology "DMR" has anything to do with ISO13485? :frust:

Cheers!
Not specifically, however, where notes in ISO 13485 refer to regional, national, international, etc. requirements, 21 CFR 820 QSR's requirements for having a DMR would be included here.
 

sagai

Quite Involved in Discussions
#4
That's actually a fair comment I think for device manufacturers whereas the particular device is marketed on that particular market.

However I still have doubts having a read of the 21CFR820 if it could be considered as such for component developer as part of the ISO13485 audit.
Sec. 820.1 Scope
...
This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance.
Cheers!
 
M

MIREGMGR

#5
We recently had an ISO 13485 audit and was issued a non-conformance for not having a DMR. Do you need to have a DMR if you are only producing a component consisting of only one item?

Any help would be appreciated.
Terminology aside, I assume that when you agreed with your NB that they would certify your QMS to ISO 13485, you provided them with some information on at least one medical device that you make, so that they and you could agree on a scope statement to go in the certificate. Is the product that you're describing that medical device?

If in fact you aren't currently producing any medical devices, and the product you're describing is in your view just a component for someone else's medical device, does the NB agree?

It sounds to me as if they think the product that you're describing as a component is in fact a medical device within the certificate scope. I'd think that issue would need to be sorted out between the NB and you.
 
I

ISODOC

#6
Thank you for the feedback.

The component is a tube, which by itself cannot be used as a device.
We are now challenged with creating DMR's which is really a Component Master Record for our purpose.

The certification does not list devices only components.

Thank you!
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Thank you for the feedback.

The component is a tube, which by itself cannot be used as a device.
We are now challenged with creating DMR's which is really a Component Master Record for our purpose.

The certification does not list devices only components.

Thank you!
Hello,

I always found it quite pointless that companies manufacturing objects that are far from being conceived as medical devices (finished or not) -- a plain "raw" tube, foe instance -- are being certified to ISO 13485. I believe ISO 900x would have been more appropriate.

Anyway, since you're already at it, here's what ISO 13485 says ("DMR" terminology aside, in essence the topic is the same):

7.3.3 Design and development outputs
(...)
Design and development outputs shall
a) ...
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) ...
If you didn't have a DMR (or its equivalent, any way you name it), I'd expect an ISO 13485 auditor to raise a NC against this "shall"; unless you excluded section 7.3 in whole and your exclusion was accepted by that auditor.

Cheers,
Ronen.
 
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