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Using a different Notified Body for ISO 13485 Certification & Device Certificate
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Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
Using a different Notified Body for ISO 13485 Certification & Device Certificate
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Some Related Topic Tags
ce mark and ce marking, class iii medical device, iso 13485 - medical device qms, mdd (medical device directive), notified bodies medical devices (nb-med), medical devices
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  Post Number #1  
Old 23rd June 2013, 04:21 PM
Donatella

 
 
Total Posts: 1
Question Using a different Notified Body for ISO 13485 Certification & Device Certificate

My company manufactures class IIa medical devices following annex II of the MDD.
Our registrar of iso9000 and iso13485 is also our notified body for CE mark.
But our NB can't mark class III devices.
My question is if we can use the company certification to ISO9000 and iso13485 (released by our actual NB) to mark ce the class III device following Annex II but using a different NB that is authorized to certify class III device.
If the answer is yes what kind of activity we have to manage with this new NB? I think that this NB have only to make the examination of the design dossier of the Class III medical device.

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  Post Number #2  
Old 23rd June 2013, 05:28 PM
Ronen E

 
 
Total Posts: 3,386
Re: Can I use different Notified Body for ISO 13485 certification & Device Certificat

Hello and welcome to the Cove

You may be right. Talk to the prospective NB(s). They may want to look at more than the class III device design dossier, depending on their policies, the specific NB you currently work with and other factors.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
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  Post Number #3  
Old 24th June 2013, 12:44 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,244
Re: Can I use different Notified Body for ISO 13485 certification & Device Certificat

Quote:
In Reply to Parent Post by Donatella View Post

My company manufactures class IIa medical devices following annex II of the MDD.
Our registrar of iso9000 and iso13485 is also our notified body for CE mark.
But our NB can't mark class III devices.
My question is if we can use the company certification to ISO9000 and iso13485 (released by our actual NB) to mark ce the class III device following Annex II but using a different NB that is authorized to certify class III device.
If the answer is yes what kind of activity we have to manage with this new NB? I think that this NB have only to make the examination of the design dossier of the Class III medical device.
You are good to work with the new NB for the class III device.
Discuss with that NB.
To authorise you to use the CE mark with the new NB number, they may need to do a MDD assessment (annex II) + the design examination the first time. Subsequently you can ask the new NB how they can maintain.
Thanks to somashekar for your informative Post and/or Attachment!
  Post Number #4  
Old 31st January 2017, 10:05 AM
Tatian

 
 
Total Posts: 8
Re: Can I use different Notified Body for ISO 13485 certification & Device Certificat

Quote:
In Reply to Parent Post by Ronen E View Post

Hello and welcome to the Cove

You may be right. Talk to the prospective NB(s). They may want to look at more than the class III device design dossier, depending on their policies, the specific NB you currently work with and other factors.

Cheers,
Ronen.
I'm in a similar situation, requiring a CE mark and already have ISO 13485 from another NB. The new NB is including full quality system and supplier audit as if I didn't have ISO 13485 certificate.

Shouldn't the notified body presume that quality systems which implement the relevant harmonized standards (EN ISO 13485:2012) conform to the requirements (MDD 93/42/EC item 3.3 and Blue Code item 5.1.6)? Although the certificate is issued as ISO 13485:2003 (not harmonized)?

"3.3. The notified body must audit the quality system to determine whether it
meets the requirements referred to in Section 3.2. It must presume that
quality systems which implement the relevant harmonized standards
conform to these requirements."
  Post Number #5  
Old 31st January 2017, 10:46 AM
Sarah Stec

 
 
Total Posts: 82
Re: Can I use different Notified Body for ISO 13485 certification & Device Certificat

Quote:
Shouldn't the notified body presume that quality systems which implement the relevant harmonized standards (EN ISO 13485:2012) conform to the requirements (MDD 93/42/EC item 3.3 and Blue Code item 5.1.6)? Although the certificate is issued as ISO 13485:2003 (not harmonized)?
The "presumption" you mention relates to the harmonized standards. So given that you don't have a quality system that conforms to the harmonized standard (because it conforms to 13485:2003 instead of :2012), the NB can't presume that your quality system complies.

The :2012 version of EN ISO 13485 clarified some provisions and gaps between the standard and the MDD. So, to your NB, it is possible that your ISO 13485:2003-compliant system does not actually comply with the requirements in the MDD.

Did they take any time at all off the overall duration?
Thanks to Sarah Stec for your informative Post and/or Attachment!
  Post Number #6  
Old 31st January 2017, 07:03 PM
Ronen E

 
 
Total Posts: 3,386
Re: Can I use different Notified Body for ISO 13485 certification & Device Certificat

Quote:
In Reply to Parent Post by Sarah Stec View Post

The "presumption" you mention relates to the harmonized standards. So given that you don't have a quality system that conforms to the harmonized standard (because it conforms to 13485:2003 instead of :2012), the NB can't presume that your quality system complies.

The :2012 version of EN ISO 13485 clarified some provisions and gaps between the standard and the MDD. So, to your NB, it is possible that your ISO 13485:2003-compliant system does not actually comply with the requirements in the MDD.

Did they take any time at all off the overall duration?
This is correct from a strictly formal perspective. To benefit the (automatic) presumption of conformity, the organization had to be certified to EN ISO 13485:2012.

On the other hand, this is a harsh and a little cynical approach, given that the normative contents of EN ISO 13485:2012 are identical to those of ISO 13485:2003. It's obvious that an organisation certified to the latter could have been just the same certified to the former, without any change or adjustment whatsoever.

I would have tried to negotiate with the prospective NB a formal certification to EN ISO 13485:2012 with just a "symbolic" audit (definitely not a full-scale one!), based on the existing ISO 13485:2003 certification. I am assuming that the registrar of the current ISO 13485:2003 certification is accredited to acceptable standards and that there is nothing wrong with the certificate, its validity etc.
  Post Number #7  
Old 21st February 2017, 11:04 AM
Tatian

 
 
Total Posts: 8
Re: Using a different Notified Body for ISO 13485 Certification & Device Certificate

No, they haven't take any time at all off the overall duration.

Apparently, It's basically up to them rather they accept it or not. Their response was that CE mark doesn't require ISO 13485 and that they have to check all quality system requirements of MDD.

And there is nothing wrong with the ISO certificate.
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