Medical devices certified by different notified bodies

[Roland chung]

Hi everyone,

We have two nebulizers (Type A and B). They are the same except for the enclosure. Can they be separately certified by different notified bodies?

 

[ScottK]

Hi everyone,

We have two nebulizers (Type A and B). They are the same except for the enclosure. Can they be separately certified by different notified bodies?

I'm not too sure on the answer to this but I have to ask why you would want to do that. It essentially doubles your cost.

 

[chris1price]

Take a look at the MDD, Annex II or Annex V, Section 3.1 on Quality Systems:

3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body.
The application must include:
.
.
.
— a written declaration that no application has been lodged with any other
notified body for the same product-related quality system,

So, as I read this, if the nebulizers were made using different quality systems, you could have 2 notified bodies, however if they are made using one quality system, you can only have one notified body.

 

[Roland chung]

I'm not too sure on the answer to this but I have to ask why you would want to do that. It essentially doubles your cost.

The enclosure of type A is normal, but type B is animal shaped. Notified body C rejects the type B, but notified body D accepts it.

 

[Roland chung]

Take a look at the MDD, Annex II or Annex V, Section 3.1 on Quality Systems:

3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body.
The application must include:
.
.
.
— a written declaration that no application has been lodged with any other
notified body for the same product-related quality system,

So, as I read this, if the nebulizers were made using different quality systems, you could have 2 notified bodies, however if they are made using one quality system, you can only have one notified body.

Yes, one QMS only. But the statement seems to say the same product.

 

[ScottK]

The enclosure of type A is normal, but type B is animal shaped. Notified body C rejects the type B, but notified body D accepts it.

What can you do to have notified body C accept the design? Surely they gave you reasons for rejection.

If you feel that they are rejecting for invalid reasons then you can escalate the issue.

but I don't think trying to get around one NB's ruling by going to another is allowable.

 

[Roland chung]

What can you do to have notified body C accept the design? Surely they gave you reasons for rejection.

If you feel that they are rejecting for invalid reasons then you can escalate the issue.

but I don't think trying to get around one NB's ruling by going to another is allowable.

The NB said nebulizer is a home used device and has potential risk for child if device looks like a toy. The household appliance standard IEC 60335-1 directly rejects the animal shaped device. We are hard to convince the current NB (C), but our justification is accepted by other one.