Test report to certify compliance with IEC 62304

EAI

Registered
#1
Hello everybody,

I am writing to ask for help on how to demonstrate compliance with IEC 62304.
We are a manufacturer of a class Im medical device. The product is HW+SW.
Currently, our TF is being assessed by an NB under MDR!

For the design and development of the SW we have used the IEC 62304 standard. In the TF we have specified that SW (class A) is developed in accordance with the state of the art and following IEC 62304:2006/A1:2015 and described how we performed each process as defined in the standard. We also added results of testing we have performed.

We have received a report of NCs, and one of them states:
"No evidence has been given that the device complies with the standard declared by the Manufacturer EN 62304: 2006 + A1: 2015. In fact, no test report (from a qualified laboratory) was provided certifying compliance with the standard, deemed essential by the NB to meet the general safety requirements of the device subject to certification".

I have just reviewed the new EU document: MDCG 2021-5
Guidance on standardisation for medical devices. This document makes it clear that the use of standards is voluntary. I don't understand why I am required to submit a test report (from a qualified laboratory) or what other internal documentation I can submit to demonstrate compliance with IEC 62340 and GSPR (MDR).

Can anyone help me with this?
Thank you very much!
 
Last edited:
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yodon

Staff member
Super Moderator
#2
I had the same thing occur several years ago. As you probably know, compliance to a harmonized standard gives you a presumption of conformity to the applicable regulations. If you get a compliance assessment report from a qualified lab, the NB can accept the results. If you try to self-assess or go with an unqualified lab, the NB will (allegedly) need to basically do their own assessment at additional cost (time and money) to you. So you can either push back and have them do the assessment or get a qualified lab to do it (obviously, either way at this point it's cost in money and time to you but if the lab does it in parallel with 60601-1 testing then there's really no additional time).
 

EAI

Registered
#3
Thank you very much for your quick response.

It really seems a bit unfair and "money-grabbing" to request an official certificate for something that is voluntary and even more so for a standard such as IEC 62304, which is to establish processes and documentation.

I also find it strange that they ask for a certificate for IEC 62304 but not for ISO 14971 for example...

But I am with you that you can enter in an infinite loop of allegations or give in and ask a lab to perform the service... it will be money and time but it will save me years of life ;-)

Regards,
 

Tidge

Trusted Information Resource
#4
Do you have established procedures that show alignment with the clauses of 62304? I suppose it is possible to establish a detailed software development plan (for a specific software effort) that explicitly maps the clauses of 62304 to the project deliverables, but that would be overkill IMO. Ultimately it is the artifacts that demonstrate compliance (for a project) with 62304, but pre-establishing the requirements is somewhat key. I think there is a subtle difference between planning for compliance and "discovering" compliance.

I can imagine that because this specific example is declared to be Class A (for which certain deliverables are not necessary per 62304) that the picture could be somewhat cloudier depending on when in the development process the assessment of safety classification was made and how it ties into the risk management process. I will disclose that this thread has conjured images of dogs and their wagging tails.

I've never had a NRTL push back asking for 'certification' to 62304; we've always provided the necessary software artifacts to both NRTLs and as part of regulatory submissions. The closest analog I can think of was walking NRTLs through our risk management process (independent of specific risk files) as part of the 60601-1 assessment.
 
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