I would like some help. We have an existing medical unit which has been Certified for CE. We would like to add a internal fan for additional cooling, because of this the shape, size and weight will change. Is CE Re-certification testing nessesary?

Oh, if only we understood CE marking/requirements.:confused:

I am not going to even try to pretend to know the answer, but I surely wish that this whole program was easily understood.

I would like some help. We have an existing medical unit which has been Certified for CE. We would like to add a internal fan for additional cooling, because of this the shape, size and weight will change. Is CE Re-certification testing nessesary?

I am not an expert in this field either, however, going under the assumption that you have changed the design, weight, and function (in Aerospace terms: Form, fit and function is affected), common sense would tell me you would need to re-certify the product.

I'm also not an expert in the medical device directives, but based on my experience with the directive I work with and the sometimes odd logic in my head, I would say "it's likely" because adding a fan would impact the power distribution of the whole unit, wouldn't it? And you'd have prove that this addition will not cause failure of any other subsystems?

Best bet would be to contact your NOBO and give him a "what if". At the very least your NOBO has to approve the change, right?

Function of the Device does not Change. Color may also change. We test to IEC 60601-1

Fuction of the Device does not Change.

However, Form, weight and fit does, correct?

Yes, Form, weight and fit changes.

Yes, Form, weight and fit changes.

Then I still would go by my common sense and say that the product needs to be re-certify (better safe then sorry). But, as I said, I am not an expert on this subject matter.

Maybe some of our CE subject matter experts can help with this question.

ScottK is correct. Your best bet is to contact your NOBO and see what they recommend. It sounds to me like a re-cert may be required. They will know your product and the CE requirements that apply much better than any of us, I would wager.

Hope this helps.

I think mostly, it depends on what was approved within your technical file. If color is a characteristic that was "approved" (reviewed) then yes, you will most likely have to provide some more info at the very least. I do know that in our case, if we should choose to add grades in the future, we have to submit the samples (data) of the "properties" for review, not necessarily undergo a whole new "production facility audit". Really, the best thing for you to do is to contact your nobo and have them tell you exactly what they want you to do. As stated before, the whole process is, for some unknown reason, shrouded in mystery and hidden from view.:(

I dont want to seem like a idiot but what is a "NOBO"?:confused:

I dont want to seem like a idiot but what is a "NOBO"?:confused:

That would be your Notified Body....The one whose CE marking number is on your product.

I'm in the same boat as the others regarding expertise (not) on the MDD; but this is not a trivial change. Electronics have changed, power consumption has changed, presumably you added the fan for a reason (to mitigate overheating risk?), etc. So a lot in the package has changed. I agree with Scott that the best approach is to discuss it with your NOBO. I (for one) would be very interested in hearing what the outcome is.

Our Notified Body has already been contacted and the modified unit (under a new product name) was added to our MDD product list. The question came up should we re-certify anyway or is it unnessesary? Our new CEO is very cautious about such things and I have to give him proof of either answer.:bonk:

Since you changed the fan you need to have your safety report updated to reflect the new fan and the entity that did the testing will determine whether it will require additional tests. I'm assuming you have a safety report prepared by a third party. If the fan is not listed in the report as a critical component(this is highly unlikely) you don't need to do anything. If the model number changed, this will also need to be reflected in the report as well as the description of the differences. I used ITS for safety and registration since they had a Notified Body in Sweden.

Since you changed the fan you need to have your safety report updated to reflect the new fan and the entity that did the testing will determine whether it will require additional tests. I'm assuming you have a safety report prepared by a third party. If the fan is not listed in the report as a critical component(this is highly unlikely) you don't need to do anything. If the model number changed, this will also need to be reflected in the report as well as the description of the differences. I used ITS for safety and registration since they had a Notified Body in Sweden.

Thanks Al this is exactly what I need

Our Notified Body has already been contacted and the modified unit (under a new product name) was added to our MDD product list. The question came up should we re-certify anyway or is it unnessesary? Our new CEO is very cautious about such things and I have to give him proof of either answer.:bonk:

I would err on the side of the CEO, better to be safe then not.

Adding a fan means changing the electrical behaviour of the system. Depending on how good the EMC isolation is, this has an effect on the limits of EN 60601-1-2 or not. You mentioned that the device has been tested for IEC 60601-1, that is one side of the medal. The other side is the emc, that has to be fullfilled. Once you exchange, add or remove any components the EMC behaviour has to be measured again. Except if you exchange identical parts against each other for example for repairing.

Justin