Understanding the relationship between 62304 and the MDD ER

[curzio.basso]

Hello everyone,

I was wondering if somehow could help me in better understanding the relationship between 62304 and the MDD ER. I guess there is no better place than the cove for this!

As far as I can see, Annex ZZ of the standard "only" says that

... within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directives 93/42/EEC, 90/385/EC and 98/79/EC.

However, I was expecting some table like the one you can find in Annex ZA of 14971, with a more explicit reference to specific ERs. Is there a specific reason why something like that is not present? Is it too dependent on the software being developed?

I apologize in advance if the question is dumb, I'm kind of a rookie in this field...

thanks!

q.

 

[Ronen E]

Hello everyone,

I was wondering if somehow could help me in better understanding the relationship between 62304 and the MDD ER. I guess there is no better place than the cove for this!

As far as I can see, Annex ZZ of the standard "only" says that


However, I was expecting some table like the one you can find in Annex ZA of 14971, with a more explicit reference to specific ERs. Is there a specific reason why something like that is not present? Is it too dependent on the software being developed?

I apologize in advance if the question is dumb, I'm kind of a rookie in this field...

thanks!

q.

Hello and welcome to (posting on) the Cove

It's up to you to analyse, decide, document and convince your NB auditors how the various relevant ERs are met through following 62304.

the whole "Z annexes thing" is still forming so it's quite possible to see different approaches in different standards.

Cheers,
Ronen.

 

[KTcons]

I think you could surely apply IEC 62304 to demonstrate compliance with M.D.D., Annex I, 12.1 bis (?For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.?), and
? risk management and processes requirements, along with EN 14971 and EN13485?.
? further requirement related to the specific software involved, where applicable

I suggest you begin drawing up your Essential Requirements? Plan, and then check the Annexes (generally ZZ) to ensure that identified standard(s) provides (full or partial) presumption of conformity.

K.T.

 

[curzio.basso]

Thanks to both,

indeed I started to draft a checklist of all requirements and the corresponding evidence of the requirement being satisfied, as well as the standard(s) the may be related.

cheers

q.

 

[J0anne]

62304 does not cover validation, which is an Essential Requirement of the MDD

No questions are dumb

 

[Phil925]

Hello and welcome to (posting on) the Cove

It's up to you to analyse, decide, document and convince your NB auditors how the various relevant ERs are met through following 62304.

the whole "Z annexes thing" is still forming so it's quite possible to see different approaches in different standards.

Cheers,
Ronen.

First post on here so please be gentle...

A question about SOUP, which was originally raised in IEC 62304 (2006). I see that some of the ER's in the new EU Medical Devices Regulations ('MDR17') can be satisfied by compliance with 62304, but I don't see any specific reference to SOUP in the MDR. Is it somehow implied via 'software components' or similar? If not, where does the regulatory requirement to do all those third-party software checks come from?

 

[BhupinderSinghPawa]

The Essential Requirements is set of 13 clauses (and many more sub clauses) specifying the safety and performance requirements that the device has to meet. The specific clause 12.1a is for software validation - software included in the device or software itself as a medical device. The method of conformity for this clause as per recognized harmonized standards (Medical devices - European Commission) is EN 62304:2006/AC:2008.

At minimum to satisfy the essential requirements you will need compliance to EN ISO 13495 and EN ISO 14971 even if it is software as a medical device; and additional standards based on the device.

 

[Phil925]

Hi Bhupinder. Thanks for your reply. I think the clause you are referring to is now 17.2 of Annex I, Chapter 2 (in MDR 2017). If so, it is an "all-embracing" requirement referring to the state of the art, "..taking into account the principles of development life cycle, risk management, including information security, verification and validation".

I appreciate that EN 62304 is the usual method of demonstrating compliance with the life cycle activities (the standard says nothing about validation) but it is not the only allowable method - since all standards are voluntary. If you go the 62304 route you are bound to have to deal with SOUP in the way the standard describes, but that was my point. We seem to be suggesting this is effectively obligatory because the notified bodies regard 62304 as the "state of the art" for software life cycle. QED.