Do NB's want the Declaration of Conformity with GMDN code?

somashekar

Leader
Admin
Is it expected by the NB's that the current Declaration of Conformity (DoC) contain the GMDN code ... ?
:thanx:
 
S

SteveK

Re: Do NB's want the Declaration of conformity with GMDN code...

Not to my knowledge. However, I do reference GMDNs in the Product Dossier section of my Technical Files, even though I have never had a request from my NB to do so.

Steve
 
M

MIREGMGR

Re: Do NB's want the Declaration of conformity with GMDN code...

My Authorized Rep expects codes as part of our DoC.

Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)
 

c.mitch

Quite Involved in Discussions
Do NB's want the Declaration of conformity with GMDN code...

Some NB's request manufacturers to add the GMDN code to the DoC and to the technical file.
It's not mandatory: never seen it neither in directive or in recommendations or meddev.
But I've never argued with NB auditors about that. If they want it, just pay the GMDN fee and add your code. An happy auditor is worth a few bucks.
 
W

wrodnigg

Re: Do NB's want the Declaration of conformity with GMDN code...

No, I do not require GMDN in any context.

(and I would request a different auditor, if one would require me spending money on that)
 

Ronen E

Problem Solver
Moderator
Re: Do NB's want the Declaration of conformity with GMDN code...

My Authorized Rep expects codes as part of our DoC.

Our NB apparently doesn't, though. (I say "apparently" because we already include codes, but our NB has never referenced them.)

Your AR has no jurisdiction granted by regulation over the contents of your DoC. Did you grant them such powers via contract?
 
Thread starter Similar threads Forum Replies Date
JoCam GMDN code in Declaration of Conformity EU Medical Device Regulations 4
R MDR vs. Machinery Directive - Single EU Declaration of Conformity EU Medical Device Regulations 2
P Distribution of "CE" Declaration of conformity under MDR EU Medical Device Regulations 3
R Declaration of Conformity for updated SaMD version EU Medical Device Regulations 2
G Need for update of Declaration of Conformity EU Medical Device Regulations 4
M Declaration of conformity MDR EU Medical Device Regulations 10
M PMA submission declaration of Conformity - DoC and SDoC US Food and Drug Administration (FDA) 3
M Declaration of conformity EU Medical Device Regulations 1
O Who writes up Declaration of Conformity (DoC)? CE Marking (Conformité Européene) / CB Scheme 4
P Declaration of Conformity for UKCA UK Medical Device Regulations 14
M Declaration of Conformity and Spare Parts EU Medical Device Regulations 0
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
D Manufacturer - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 1
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 15
J EU Declaration of Conformity for Class I EU Medical Device Regulations 3
CharlieUK Informational ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE CE Marking (Conformité Européene) / CB Scheme 0
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
L MDR 745 - EU Declaration of Conformity - Signature Requirements EU Medical Device Regulations 3
A EC declaration of conformity - In the event clients ask for a copy CE Marking (Conformité Européene) / CB Scheme 12
L Content of Declaration of conformity (MDR) EU Medical Device Regulations 1
N Declaration of Conformity for Product from Supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
I Who is responsible for signing the Declaration of Conformity and what is their liability Imported Legacy Blogs 0
F Declaration of Conformity with Electrical & Electronic Medical Devices EU Medical Device Regulations 2
A 93/42/EEC Declaration of Conformity and Harmonized Standards EU Medical Device Regulations 12
K DoC (Declaration of Conformity) for Custom Made Medical Devices EU Medical Device Regulations 1
M R&TTE Directive - Declaration of Conformity Requirement CE Marking (Conformité Européene) / CB Scheme 5
B Cost to a dealer for a "Declaration of Conformity " "Gost-R" in Ukraine? EU Medical Device Regulations 2
J Declaration of Conformity for an Investigational product EU Medical Device Regulations 3
JoCam ATEX - Responsibility for a Declaration of Conformity Various Other Specifications, Standards, and related Requirements 7
M Declaration of conformity for "orthopedic soft goods" EU Medical Device Regulations 5
M Revising Declaration of Conformity and Classification Rationale EU Medical Device Regulations 2
M Content Requirements for a Declaration of Conformity (CE Marking) CE Marking (Conformité Européene) / CB Scheme 1
J RoHS2 Declaration of Conformity requirements RoHS, REACH, ELV, IMDS and Restricted Substances 3
Q Medical Device Declaration of Conformity Approval Requirements EU Medical Device Regulations 8
C PED Documentation (certificate and declaration) for Conformity Validation CE Marking (Conformité Européene) / CB Scheme 3
S Is there an Expiry Date for "Declaration of Conformity" (DOC) for Medical Devices? EU Medical Device Regulations 4
rob73 Harmonised Standards on DoC (Declaration of Conformity) EU Medical Device Regulations 10
N Declaration of Conformity from the Notified Body for our Surgical Glove Class IIa CE Marking (Conformité Européene) / CB Scheme 6
I Question on Declaration of Conformity for device subcategory or generic device groups EU Medical Device Regulations 2
E What is missing in the attached Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
rob73 Length of validity of a self certified Declaration of Conformity (DoC) for CE mark EU Medical Device Regulations 4
R Declaration of Conformity Paper Copy Shipped with Product? CE Marking (Conformité Européene) / CB Scheme 1
D Declaration of Conformity for a Class III Medical Device Implant EU Medical Device Regulations 5
S Declaration of Conformity ? True site of Manufacture? CE Marking (Conformité Européene) / CB Scheme 4
T Declaration of Conformity acording to the ZLC 3.9 A4 Conformity Assessment EU Medical Device Regulations 5
A EC Technical File DoC (Declaration of Conformity) Content Requirements EU Medical Device Regulations 8
G Declaration of Conformity and Standards - List of standards on your DoC's? CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom