Using IEC 60601-1 2nd Edition for "Evaluations"

[Shamann2]

I have a client that has a version of a medical device tested to meet 60601-1 2nd edition. That's right - 2nd edition. They want to ship out that product for "Evaluations" in clinical settings, some evaluations with IRBs, some perhaps not. Also some for "demos" by sales reps. The head of engineering and I are both uncomfortable with this approach.

They also said that they received a 510(k) right at the deadline for the 2nd edition and were granted a waiver to sell the products for 5 or 10 years. Has anyone heard of this?

This is not my area of expertise so comments and guidance are greatly appreciated.

 

[Ronen E]

I have a client that has a version of a medical device tested to meet 60601-1 2nd edition. That's right - 2nd edition. They want to ship out that product for "Evaluations" in clinical settings, some evaluations with IRBs, some perhaps not. Also some for "demos" by sales reps. The head of engineering and I are both uncomfortable with this approach.

They also said that they received a 510(k) right at the deadline for the 2nd edition and were granted a waiver to sell the products for 5 or 10 years. Has anyone heard of this?

This is not my area of expertise so comments and guidance are greatly appreciated.

Hi,

First off, 510(k) - The transition deadline was some years back (2013 if I'm not mistaken). It's possible that they got cleared earlier, but not likely if their 510(k) is recent. It should be easy to verify. "Waiver" - none is needed. There is no FDA requirement to "move with the times". Once a 510(k) is cleared there's no need to upgrade to newer versions - the clearance is indefinite, unless the design changes significantly.

back to your general situation - there's a regulatory aspect and a general engineering / risk management aspect.

The regulatory aspect is simple - you need to look at where the device is going to be used and see what the applicable requirements are. I wouldn't take it for granted that 3rd edition compliance is required everywhere, for every purpose.

From the general aspect - 2nd edition is not that "bad". I believe that it still holds significant value. It is up to careful analysis and judgement. I would look to understand what exactly is planned under "evaluations in clinical settings", "evaluations by IRBs" and "demos by sales reps". The biggest question is: Will it be used on humans? As for basic safety for operators/demonstrators, I would tend to think that full certified compliance with the 2nd edition provides a reasonable safety assurance, but I know nothing about the device.

Cheers,
Ronen.

 

[Shamann2]

Ronan, thank you so much for your reply. I do understand about the 510(k) being "permanent", but isn't there some requirement, perhaps by hospitals or local jurisdictions, to have products meet current safety and emissions standards? Besides the US, does the device need to meet current standards for Europe and Canada? I'm trying to get answers for the engineering staff who are of a different mindset than some other folks in the company.

 

[Ronen E]

but isn't there some requirement, perhaps by hospitals or local jurisdictions, to have products meet current safety and emissions standards?

That's a very broad question. Each hospital and local government may have different policies, requirements and expectations, so you'd have to reasearch them individually.

Electrical safety also exceeds the medical devices regulatory framework - any electrical equipment needs to be safe and there are various certification schemes around. This is not my speciality, I was addressing the medical devices regulatory aspect specifically. If you search Elsmar you'll find more than a few discussions mentioning electrical equipment safety qualification.

Besides the US, does the device need to meet current standards for Europe and Canada?

Yes, in the EU there's an explicit requirement to catch up with the "state of the art" which is interpreted as keeping up with the latest harmonized revision of a standard.