I'm asking this question here instead of the CE forum as I would like to better understand the implications of pursuing CE marking for our as-yet un-marketed class 2b medical device.

When I enquired about ISO 13485 and CMDCAS registration, the auditor asked whether I also needed CE (which I declined at that point) - Is this to assess the QMS for suitability for CE? Doesn't 13485 and the Canadian CMDCAS provide sufficient requirements for the QMS?

Now from the product point of view, as I mentioned it's not yet being marketed so it doesn't have Health Canada or FDA approval. But these are underway. How much more work is it to obtain the CE mark, assuming 60601-1 is granted? Perhaps this product question is better asked in the CE forum...?

Just trying to get a sense of the workload and priorities to help the marketing group decide whether marketing outside of North America is sensible.

I'm asking this question here instead of the CE forum as I would like to better understand the implications of pursuing CE marking for our as-yet un-marketed class 2b medical device.

When I enquired about ISO 13485 and CMDCAS registration, the auditor asked whether I also needed CE (which I declined at that point) - Is this to assess the QMS for suitability for CE? Doesn't 13485 and the Canadian CMDCAS provide sufficient requirements for the QMS?

Now from the product point of view, as I mentioned it's not yet being marketed so it doesn't have Health Canada or FDA approval. But these are underway. How much more work is it to obtain the CE mark, assuming 60601-1 is granted? Perhaps this product question is better asked in the CE forum...?

Just trying to get a sense of the workload and priorities to help the marketing group decide whether marketing outside of North America is sensible.You're in the right forum. You need to meet the MDD requirements (http://elsmar.com/Forums/attachment.php?attachmentid=3000)as well to CE mark your devices.

Hi Le Chiffre
It all depends on the device. It could be that there are not many additional requirements. You will have to meet ISO 14971 for risk management.

It is best to speak to a notified body who can get a technical expert to tell you what are the requirements for your device.

If you send me a private message, I can put you in touch with one.

Danny

Thanks Danny. My registrar was going to be my next point of call.
I've used ISO 14971 to create a risk management plan as part of my CMDCAS registration and in preparation for FDA.

Thanks Al for the MDD reminder. I'd forgotten about that.