Certification services for ISO 13485, CMDCAS 13485, and CE Markings

[sabrina.qa]

I would like to apologize off the bat if this is terribly uninformed.

I've inherited a QMS with certifications for ISO 13485, CMDCAS 13485, and CE Markings.

If we are certified for CMDCAS 13485 anyway, which is ISO 13485 + CMDR requirements, is it necessary for us to also have the cert for the original flavour ISO 13485?

 

[Gert Sorensen]

Re: Certification services

If you are located outside of the EU and provide products for the EU I believe that you will need a "clean" ISO 13485 certification. The Canada version CAN/CSA ISO 13485 is in terms of compliance not the same as the EN ISO 13485.

 

[sabrina.qa]

Re: Certification services

From what I understand it is BSI EN ISO 13485 that we're certified to, not CAN/CSA ISO 13485, and our CMDCAS cert is because the QMS addresses the CMDR requirements.

 

[WAF64]

Re: Certification services

If you're selling in EU and Canada you need both certifications.
Cheers

 

[sabrina.qa]

Thanks WAF64

I hope this isn't me being dense

but I understood the EC Certificate (Directive 93/42/EEC, Annex V) was what I needed to sell in the EU. (1 certificate)

And then an ISO 13485 certificate issued by a CMDCAS recognised registrar to sell in Canada. (2nd certificate) (Does not specify CAN/CSA) (says SCC)

We have a 3rd certificate and I am (clearly) struggling with the need to have it. It is EN ISO 13485 (says UKAS) - who will refuse the SCC cert above if that is offered in lieu of this one?

 

[Ronen E]

You should ask the NB who issued your EC certificate if they will accept the SCC one. Please also consider that you might need ISO 13485 certification for other markets.

Normally when being EC certified you get 2 certificates - one for EN ISO 13485 and the EC certificate. Usually they both originate from the same NB audit (but not necessarily).

Cheers,
Ronen.

 

[WAF64]

Sabrina,
if you want to sell medical devices in EU you are required to meet the quality system requirements outlined in the directive (Annex II and Annex V specifically), but how you are going to do so is left to you.
ISO 13485 is a voluntary tool available to you to meet the quality system requirement. However, although ISO 13485 is voluntary, it is actually considered “the standard” for companies that sell medical devices in Europe. If you are in compliance with ISO 13485 you are presumed to meet the quality system requirements of the MDD 93/42 EEC directive.

Finally, the conformity assessment route may vary based on your device class, so I strongly suggest you to contact your notified body to check out possible alternative conformity assessment routes.

 

[sabrina.qa]

You should ask the NB who issued your EC certificate if they will accept the SCC one. Please also consider that you might need ISO 13485 certification for other markets.

Normally when being EC certified you get 2 certificates - one for EN ISO 13485 and the EC certificate. Usually they both originate from the same NB audit (but not necessarily).

Cheers,
Ronen.

Hi Ronen,

The same NB issued all 3 certs from the same audit.

My two ISO 13485 certificates look like this:

First one -

"the management system of [company/address] has been assessed and certified as meeting the requirements of

ISO 13485:2003
EN ISO 13485:2012

for the following activities

(activities)
(expiration)
(NB address) (UKAS stamp)"

Second one -

"the management system of [company/address] has been assessed and certified as meeting the requirements of

ISO 13485:2003

for the following activities

(identical activities)
(expiration)
(registrar address) (SCC stamp)
CMDCAS recognised registrar"


In what market would the second one be rejected?

It still seems to me that I should be able to satisfy all regulatory authorities with the EC certificate and the second ISO 13485 certificate. Two ISO 13485 certificates seem like overkill!

 

[Gert Sorensen]

Certificate 1 is for the EU (EN ISO certification)

Certificate 2 is for Canada (CMDCAS)

 

[Ronen E]

Hi Ronen,

The same NB issued all 3 certs from the same audit.

My two ISO 13485 certificates look like this:

First one -

"the management system of [company/address] has been assessed and certified as meeting the requirements of

ISO 13485:2003
EN ISO 13485:2012

for the following activities

(activities)
(expiration)
(NB address) (UKAS stamp)"

Second one -

"the management system of [company/address] has been assessed and certified as meeting the requirements of

ISO 13485:2003

for the following activities

(identical activities)
(expiration)
(registrar address) (SCC stamp)
CMDCAS recognised registrar"


In what market would the second one be rejected?

It still seems to me that I should be able to satisfy all regulatory authorities with the EC certificate and the second ISO 13485 certificate. Two ISO 13485 certificates seem like overkill!

If they all came from the same audit and you didn't pay extra for the 3rd certificate, why would you care?