Rework Devices placed on the market - IEC 60601-1 Requirements 3rd edition

Mawos78

Starting to get Involved
#1
Good morning,

My company is currently working to get all MEE devices compliant against 60601-1 3rd edition. Some products have to be slightly modified, to pass the test and/or the 3rd edition requierments.
Do we have to rework medical electric devices that have been already placed on the market before June 1st 2012 and are fullfilling 2nd edition requirements? Or are these modifications just needed for products placed on the market after June 1st 2012? And therefore the modifications do not have to be made on devices that have been sold (let's say) 1year ago?!?

What is your thought on this?

Thanks Martin
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#2
Re: Rework devices placed on the market - 60601-1 3rd edition

Hello Martin and welcome to the Cove!

The answers to your questions really depend on the regulatory system in which you are selling the device.

As generic examples, in the US you only have to comply with the newer standards for newly approved devices. In the EU, you have to keep the state of the art, which means that, if you use standards to gain presumption of conformity with the requirements of the directives, changes in standards (considered state of the art in the EU), means you have to evaluate and possible retest devices.

However, those needs are only for devices which are to be "approved" or placed on the market (in the case of the EU), not the ones on the market.
 

Mawos78

Starting to get Involved
#3
Re: Rework devices placed on the market - 60601-1 3rd edition

Marcelo,

thanks for your clarification on this.
I was specificly asking for the EU Markets. My concern was that we have to rework/modify all devices already palced on the market, too, if for these a modifciation to pass 3rd edition testing is necessary. This would have ment a significant workload!

Great thanks,

Martin
 

Peter Selvey

Trusted Information Resource
Trusted
#4
Everywhere in the world has the same ruling on this: after the device is on the market there is no obligation to update to new standards.

It would be impossible to rework devices already on the market. In general there is no requirement for manufacturers to trace where the devices are sold, the cost would be incredible, and rework probably dangerous. No government in the world would consider such action reasonable.

If there is a serious safety issue, which becomes known through the application of standards to old designs, it could trigger recall provisions. But it would have to be pretty serious for this to occur.
 

Roland chung

Quite Involved in Discussions
#5
Hello Peter,

Based on this topic, I would like to ask a question. Recently, we received a notice from our NB. The notice said the NB Mark Certificate would be cancelled after June 1st, 2012 for power supplies which certified to IEC/EN 60601-1 2nd edition. Do you think it is reasonable?

I think the NB Mark Certificate should not be withdrawn. Because of many end products also need 2nd edition approved power supplies even after June 1st, 2012.
 

Peter Selvey

Trusted Information Resource
Trusted
#6
Technically a power supply is not a medical device, so neither regulatory requirements nor IEC 60601-1 apply.

Certification companies still "certify" power supplies as a component. This is a private issue so basically they can decide what they like.

In principle, the intention behind power supply certification is to make life easier when testing the end product (medical device), and also during follow up inspections for product certification like NRTL/SCC. Since many medical devices can use 2nd edition for years to come (because of delayed particulars), it does not make much sense to withdraw power supply certificates in June. I don't think the testing companies have the capacity to retest before June anyway. So it does sound odd to cancel the certificates in June. But again, it's a private decision.

If it is purely European CE marking, regulation does not require a certified power supply, so you could deal with the situation as you see fit. For US, Canada (NRTL/SCC), you need to check your product certification scheme whether a withdrawn certificate is a problem.
 

Roland chung

Quite Involved in Discussions
#7
You are right. The NB Mark is private and they can decide what they like. They said the deadline of EN version in OJ is June 1st, 2012. So all the certificates based on EN 60601-1_2nd edition only shall be withdrawn, regardless what type of the products is.
 
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