Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software.

W

Watchwait

#21
After stumbling on this thread by accident, I came across a PP presentation from FDA regarding Global Hatrmonization, specifically EN 60601-1 recognition, more specifically EN 62304 compliance. Bottom line - although FDA does not yet recognize 60601-1, they clearly intend to do so. However, if one is selling to Europe and is ISO 13485 certified AND voluntarily claiming compliance to 60601-1 (as are we), compliance with EN 62304 is mandatory (see slide #11 of the attached FDA presentation).
 

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Marcelo

Inactive Registered Visitor
#22
Hwlloe Watchwait

Sorry to disagree, but any standard in Europe is voluntary (as you yourself know by our discussion in the thread http://elsmar.com/Forums/showthread.php?p=237965#post237965). Even if IEC 62304 was a collateral IEC 60601-1-X standard - which it´s not - and IEC 60601-1 now make all collateral standards normative for compliance with the general one, still the ultimate mandatory requirement of CE MArking is compliance with the essential requirements, not with standards, so it would not be mandatory in any way.

This said, i do hope that everyone begin to use IEC 62304 (and it´s "sister" TR 80002 Medical device software – Guidance on the application of ISO 14971 to medical device software, which is a twin of the AAMI TIR standard mentioned in the presentation) as they clarify what is expected as software development lifecycle processes. In fact, one of the reasons IEC 62304 was developed was that, although development lifecycle processes was an old requirement (it comes from the software engineering field), a lot of companies didn´t have any idea what was expected (for example, a lot of companies don´t have software engineers developing software, so they do not have a formal training in software engineeringmethodologies).
 
W

Watchwait

#23
No disagreement here at all. Your points are spot on. Consider, however, this fact: on our recent Notified Body audit, I was told to reference IEC 62304 in our Technical File for a Class IIa product as this was the current standard to demonstrate compliance with the ER.

Also your point about voluntary compliance with harmonized standards, while, again, is technically correct, the path to successfully demonstrate compliance with the essential requirements WITHOUT referencing a harmonized standard is typically far more difficult that compliance with the HS. So while voluntary compliance is technically the correct term, it is typically the less burdensome approach to demonstrating compliance to the ERs.
 
P

pheuvelmans

#24
Hi Alexander and others,

Can anyone of you indicate whether the EN 62304 standard is mandatory to be used within ISO 13483? We're currently runnign an ISO 13485 recertification audit and the auditor announced that he was going to our software development processes, using 62304 as reference.

A quick reply would be very helpfull, as the audit takes place now.

Thanks.

Pierre.
 

Marcelo

Inactive Registered Visitor
#25
As i said in previous posts, no standards are mandatory; as pointed, they´re the easiest way to show compliance. There´s no mandatory standards to use with ISo 13485. In fact, even ISO 13485 is not mandatory.

However, harminized stadards are used as the "golden standard!, so, if you do not use them, you have to show that what you do is similar to them. If you show your auditor that what you do has the same level of safety and compliance with the essential requirements as would be the case if you used EN 62304, the auditor would have to accept that.

Keep in mind, however, that EN 62304 was harmonized due to the revised MDD which clarified the software requirements.
 
A

alexander73

#26
You are lucky 'cause I've just looked into my email. If you produce software - yes, 62304 is mandatory since July 1, 2007.
 
P

pheuvelmans

#27
You are lucky 'cause I've just looked into my email. If you produce software - yes, 62304 is mandatory since July 1, 2007.
thanks for the quick reply Alexander.

However, your answer seems to conflict with marcelo's.
can you explain this?

Pierre
 
A

alexander73

#28
Marcelo is right when he states the need of provement that your actions about medical software satisfies to the requirements of 62304. Anyway, it would be easy to implement this standard comparing to a "homemade" system.
 
D

danpa

#29
13485 does not call out 62304. The 62304 'requirements' are stricter and more detailed than what 13485 requires. 62304 should not hold up certification to 13485.
That said, some countries are moving toward require 62304 compliance so at some point it will likely be required.
 
W

Watchwait

#30
I'll jump in w/my :2cents:

RE: Standards. Once again Marcelo is right on the target. No standard is mandatory. However, I will indicate that in my experience it is always easier to show compliance with a standard than to conceive, implement and document an alternative to the standard. Is this always the case? No, but I would say 9 times out of 10 it is the case. Auditors, not surprisingly, are more comfortable with standards, particularly harmonized standards.

RE: EN 62304. Our Notified Body has indicated that we need to reference compliance to EN 62304 in the Essential Requirements section of our Technical File. Yes, we produce software as part of our medical device. And yes, I know we have the option of developing our own approach the the REQUIREMENTS of the MDD. But as noted above, we will no doubt detail the requirements in 62304 and reference compliance with the standard.
 
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