Does my company need to be ISO 13485 registered?

I

IRSmith

#1
Hello and help! :bigwave:
My company is a small subcontract assembler of PCBs, cables and box builds, we do not have our own products........

Until now. We have developed an electronic product/device for use by health professionals (psychiatrists) for treating stress (sorry can't say anything more than that).

We are planning to sell only in the UK at the moment, with a possible expansion in the EU and I appreciate 'the world' is too big a question to ask here!!

From research I believe that,
1) this product would be a Class I product?
2) Therefore, our company would not be required to be ISO13485 registered (we are ISO9001 & AS9100)?
3) We do not have to CE mark through a notified body?

Basically, am I right and if not, can you please educate me.

Thanks
 
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medwise

Involved In Discussions
#2
Hello,

You are right if your product will be classified as a class I medical device as per the MDD rules. ISO 13485 certification is not mandatory as long as you can demonstrate compliance with Essential Requirements. Having ISO 13485 is an easier way to demonstrate this. However, in case of class I device, ISO 9001 is fine too. Therefore, your understanding is right.

Also, for class I you do not need a CE mark through NB. Class I devices are self-certified.

Hope this helps.

Kind regards
Romit:tg:
 

somashekar

Staff member
Super Moderator
#3
Hello and help! :bigwave:
My company is a small subcontract assembler of PCBs, cables and box builds, we do not have our own products........

Until now. We have developed an electronic product/device for use by health professionals (psychiatrists) for treating stress (sorry can't say anything more than that).

We are planning to sell only in the UK at the moment, with a possible expansion in the EU and I appreciate 'the world' is too big a question to ask here!!

From research I believe that,
1) this product would be a Class I product?
2) Therefore, our company would not be required to be ISO13485 registered (we are ISO9001 & AS9100)?
3) We do not have to CE mark through a notified body?

Basically, am I right and if not, can you please educate me.

Thanks
Until now. We have developed an electronic product/device for use by health professionals (psychiatrists) for treating stress (sorry can't say anything more than that).
Design, develop and manufacture is what I read and see of an electronic medical device...
We are planning to sell only in the UK at the moment, with a possible expansion in the EU and I appreciate 'the world' is too big a question to ask here!!
UK is in the EU. So you are to meet the MDD requirements
1) this product would be a Class I product?
If you have assessed your device classification correctly per MDD, you can certainly move ahead.
2) Therefore, our company would not be required to be ISO13485 registered (we are ISO9001 & AS9100)?
While ISO13495:2003 is the international standard for medical devices to meet regulatory purpose, EN ISO13485:2012 is the EU harmonized standard. Both have almost the same requirements detailed.
3) We do not have to CE mark through a notified body?
Address the class 1 device accordingly. You may not need a NB
While you are already an ISO9k and AS certified, see how well you can also integrate the ISO13485 / EN ISO13485. They will come handy in the long run.
 
Last edited:

sagai

Quite Involved in Discussions
#5
Sounds like a perfect timing to compile a regulatory plan for your products considering target markets, sales channels and products to be marketed on those market!
Regards
 

DannyK

Trusted Information Resource
#6
Hello and help! :bigwave:
My company is a small subcontract assembler of PCBs, cables and box builds, we do not have our own products........

Until now. We have developed an electronic product/device for use by health professionals (psychiatrists) for treating stress (sorry can't say anything more than that).

We are planning to sell only in the UK at the moment, with a possible expansion in the EU and I appreciate 'the world' is too big a question to ask here!!

From research I believe that,
1) this product would be a Class I product?
2) Therefore, our company would not be required to be ISO13485 registered (we are ISO9001 & AS9100)?
3) We do not have to CE mark through a notified body?

Basically, am I right and if not, can you please educate me.

Thanks
I would confirm the classification with a notified body just to be sure. Once the classification is clear, then it would be easy to provide your company with a plan.
 
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