EU Authorized Representative for a Class I Medical Device

Edward Reesor

Trusted Information Resource
#1
Greetings all, I hope all are well during these times.

If someone could BUMP me to the right thread or offer advice to my situation, it would be greatly appreciated.

* Canadian manufacturer of Class I and IIa medical devices

* Was previously with a NB but withdrew from the EU market when the Rev 4 was announced

* Have a request for a small amount of our Class I devices

* Since we self declare and can label it with "CE" easily, do we still require a EU Rep since there is no NB involved?

*With low margins, is it even worth it to do so

Thank you all for your response.
 
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mihzago

Trusted Information Resource
#2
Yes, EAR is required for any company that offers products in EU and does not have a local presence in the EU, irrespective of device classification.
You can find a reasonable one for about $1500/year.
 

Edward Reesor

Trusted Information Resource
#3
Thank you! That's what I thought but needed confirmation from my esteemed colleagues (i.e. not my personal interpretation of the regs).
 
#4
My product is a Digital Acuity Chart (VDAC) is a self-administered digital eye chart device ( a USA company) the company has confirmed the device do not have measuring functions because of that it should be classified as class I. I would like please some advice to better understand the process for confirming classification with a notified body and then if it is class 1, what that means for completing the CE marking process. thanks a lot !!!
 

mihzago

Trusted Information Resource
#5
You should document the classification and your rationale. If you're certain it is not class IIa or higher, or class I measuring/sterile, then you don't need to interact with a notified body.
You have to find an EU Authorized Representative; they will review your classification justification and other required documentation. If they agree with everything, they'll submit registration to the local CA (Competent Authority). If CA accepts the information, they'll issue a certificate, if not you may have to start over by re-classifying the device at which point you may have to engage a NB.
 
#6
You should document the classification and your rationale. If you're certain it is not class IIa or higher, or class I measuring/sterile, then you don't need to interact with a notified body.
You have to find an EU Authorized Representative; they will review your classification justification and other required documentation. If they agree with everything, they'll submit registration to the local CA (Competent Authority). If CA accepts the information, they'll issue a certificate, if not you may have to start over by re-classifying the device at which point you may have to engage a NB.
thank you so much!! the device do not measure anything and not in contact with the body the company hope to avoid the NB and the Quality system that I understand its not needed for Class I device. so the recommendation in this case should be to address the final evaluation with an EU Authorized Representative is that correct? the certificate issued by the CA will be the CE marking?
 

Rincewind

Involved In Discussions
#7
Take the MDR and check Annex VIII, the rules will tell you what class your medical device is. If you struggle maybe consult the MEDDEV 2. 4/1 rev. 9 (it was written for the MDD but it will give you an idea about the thinking and application of the rules).

If you conclude that your device is indeed class I, you need a quality management system and prepare a technical documentation (Annex II and III).
Then you can draw up a Declaration of Conformity (DoC) as per Annex IV. For class I devices no Notified body is involved.

The EU Representative basically just acts a contact for the competent authority in the EU. Your EU Rep can then proceed as mihzago already lined out.
 
#8
Take the MDR and check Annex VIII, the rules will tell you what class your medical device is. If you struggle maybe consult the MEDDEV 2. 4/1 rev. 9 (it was written for the MDD but it will give you an idea about the thinking and application of the rules).

If you conclude that your device is indeed class I, you need a quality management system and prepare a technical documentation (Annex II and III).
Then you can draw up a Declaration of Conformity (DoC) as per Annex IV. For class I devices no Notified body is involved.

The EU Representative basically just acts a contact for the competent authority in the EU. Your EU Rep can then proceed as mihzago already lined out.
thank you so much !! really appreciated!!
 
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