Distribution of "CE" Declaration of conformity under MDR

[Pzimmermann92]

Good Morning,

As i could not find a clear statement in the MDR or related websites, maybe i can find some clarification here.

Our medical device (Class IIa) on the market since 2012 (ECG monitor) is untill today supplied with a printed Declaration of conformity (DoC) which is added in each device packaging box.

Is there a need to supply the DoC with each product, or is it sufficient enough to have the CE Mark on the packaging/device(as already in place) and provide the DoC via the website, or upron request? Background of this question, i am updating the device manual/IFU to MDR requirements, and was asking where the DoC should be best placed (or should it be part of the manual?)

I hope you can help me somehow further, i would appreciate it!

Best Regards,

Patrick Z.

 

[Jean_B]

Hello Patrick,

No. The DoC must be available. There is no requirement under the EU MDR to provide it alongside the device to the customer.
You must keep it available after ending product sales as well, as it must be produced upon request by i.e the competent authority.
Sometimes some markets/customers may require a Certificate of Conformity, which is something different.
Also read the EU's blue guide (not the 2016 one, but the newer 2022 one) for the bigger structure surrounding this.

Greetings, Jean

 

[Pzimmermann92]

Hello Jean

Thank you very much for your clarification.
Information found over the internet to support the understanding of the "technical" language of the MDR can sometimes be confusing, Clarification over this forum helps me a lot.

Best regards!

Patrick

 

[Jean_B]

No problem. Good to see the device make the jump to EU MDR. Also check compliance against the EU MDR's harmonized standards via Medical devices (europa.eu), especially EN ISO 14971:2019/A11:2021.
For your device, check whether (and when) standards already available are requested to be harmonized via the standardization requests at eNorm Platform (europa.eu) . Amongst others

• EN 60601-2-25:2015
• EN 60601-1-11:2015+A1:2020
• EN 60601-1-6:2010+A1:2015+A2:2020
• EN 60601-1:2006+A1:2013+AC:2014+A12:2014 +A2:2020

are slated for 27th of May 2024, though they may gain Z annexes stating (implicit) further expectations and clarifications through new EN edition publications.

Best of luck.