Declaration of conformity as per EU MDR (2017/745)

Regulatory

Starting to get Involved
#1
Dear All,
Greeting of the day!
We are drafting our DOC per MDR (2017/745) (Annex IV) for class IIB medical devices. There is one query regarding content of DOC i.e. applicable Harmonized standard is mandatory part of DOC or it's voluntary please advice..

Thanks and regards
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
There is one query regarding content of DOC i.e. applicable Harmonized standard is mandatory part of DOC or it's voluntary please advice..
The requirements for the MDR declaration of conformity, according to Annex IV, don't mention harmonized standards.
All that's mentioned is the need to reference any Common Specifications (CS).

I will admit, this is an odd omission, as the requirements for other Directive declarations do require reference to applied harmonised standards.
...but, strictly by the text of the current MDR, it appears that reference to harmonised standards on an MDR declaration of conformity is not required.
 

yodon

Staff member
Super Moderator
#4
It's always been the case that compliance to particular standards is voluntary. Compliance to harmonized standards gives you presumption of conformity to the relevant requirements (MDD / MDR). If you choose not to comply with the harmonized standards, the conformity assessment path will be more difficult since the reviewers have to dig deeper to assess conformity.
 
#6
Fully agree with the above. However, a notified body recently insisted to see the standards listed on the CE DoC while referring to the blue guide and guidance like MDCG 2020-2-1. As far as I know, there was a clear decision during writing the MDR not to require standards in the DoC (resulting in annex IV only mentioning CS's). We will probably add the standards to solve the nonconformity but this will lead to more work with updates especially since we need the DoC translated in many EU languages. :(
 
Thread starter Similar threads Forum Replies Date
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
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
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
SteveK 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
P Lisbon customs requires for MDD declaration of conformity? EU Medical Device Regulations 6
J Declaration of Conformity - Updating the DofC to MMD 2007/47/EC EU Medical Device Regulations 4
N Declaration of Conformity - New directive, new declaration CE Marking (Conformité Européene) / CB Scheme 2
A Non-EU countries who use your EC Certificate & Declaration of Conformity Other Medical Device Related Standards 3
A Who signs your Declaration of Conformity? ISO 13485:2016 - Medical Device Quality Management Systems 16
M Procedure for Declaration of Conformity EU Medical Device Regulations 19
H Lot numbers in Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 9

Similar threads

Top Bottom