EC declaration of conformity - In the event clients ask for a copy

Alyana

Starting to get Involved
#1
Hello Cove,

Regarding EC declaration of conformity, in the event clients asking for a copy of it, could we provide them a copy/xerox extracted from Technical File, or print a new one? Should it be freshly signed and dated following to each client request?

Thanks,
Nur
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Nur,

I don't see anything wrong with a photocopied duplicate, but customers may always ask for whatever they feel like (it's up to you whether to accommodate - a business decision).
 

Alyana

Starting to get Involved
#3
Hello Nur,

I don't see anything wrong with a photocopied duplicate, but customers may always ask for whatever they feel like (it's up to you whether to accommodate - a business decision).
Hello Ronen,

Thanks for your reply. If it is to be reprinted, can I put new date as per the signing date?

Regards,
Nur
 

Rincewind

Involved In Discussions
#4
I think you can just send them a copy of the existing one, some companies even habe the DoC on their website for download, it is up to you.
 

Marcelo

Inactive Registered Visitor
#6
If you change the date of the declaration of conformity, you will have to update them anywhere it's used (including with the NB, if applicable). In the case you mentioned, it's better to simply use the declaration you already have (please note that under the MDR, the declaration will need to be in several places and probably in several languages, so you really do not want to change it at will).
 

Ronen E

Problem Solver
Staff member
Moderator
#7
If you change the date of the declaration of conformity, you will have to update them anywhere it's used (including with the NB, if applicable). In the case you mentioned, it's better to simply use the declaration you already have (please note that under the MDR, the declaration will need to be in several places and probably in several languages, so you really do not want to change it at will).
I understood the question not as re-issuing the DoC but simply reprinting (or photocopying) and wet-signing the copy* and wet-adding a note of the date of signature. No more, no less.

*) Obviously such action is not necessary from a regulatory perspective, so I addressed it from a purely-commercial perspective, where a supplier is trying to please the customer without breaking any rules... In such settings, such a wet-signature could mean various things (e.g. authenticating the copy and confirming that the original is still in effect, but this is just a hypothetical example), so it would come down to agreement between the supplier and the customer.
 

chris1price

Trusted Information Resource
#8
In most cases, a photocopy has been sufficient. Occasionally I have been asked to certify it is a copy of the original or to have it notarized. I would not re-issue a DOC for the reasons Marcelo raises.
 

CharlieUK

Quite Involved in Discussions
#10
You should send a copy of the latest version that you issued - A DoC should be a revision controlled document just like schematics, user manuals etc. as it needs to be traceable to a point in time.
A "Declaration of Conformity" is a Declaration that all ongoing manufactured products are compliant with the relevant legislation.

I would never send a freshly signed copy - to me it looks like you hadn't demonstrated compliance in the correct way and were just writing a quick DoC because someone asked you for one.
 
Thread starter Similar threads Forum Replies Date
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 2
JoCam GMDN code in Declaration of Conformity EU Medical Device Regulations 4
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
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
somashekar Do NB's want the Declaration of Conformity with GMDN code? EU Medical Device Regulations 14
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
R Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/ECC CE Marking (Conformité Européene) / CB Scheme 9
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M Declaration of Conformity - Structuring EU Medical Device Regulations 2
A Declaration of Conformity for non-CE Mark products CE Marking (Conformité Européene) / CB Scheme 2
somashekar Intent of "Declaration of Conformity" - MDD ANNEX II EU Medical Device Regulations 8
Q Authorized Representative - Declaration of Conformity Signator CE Marking (Conformité Européene) / CB Scheme 4
J Standard Version(s) on Declaration of Conformity (DoC) - Necessary or required? EU Medical Device Regulations 2
J Notified Body on Class I Declaration of Conformity? EU Medical Device Regulations 4

Similar threads

Top Bottom