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Class II Medical Device Conformity Assessment Route according to Annex V only

S

silentassassin

#1
Hi folks,

We recently got our CE marking for several of our IIa Medical Devices.
The certificate provided by the NB states that the conformity assessment route was according to Annex V ONLY even the scope of the audit included examination of the technical file.
I think that no class IIa medical can be CE marked according to Annex V only; it should be either according to Annex II (section 4 excluded) Full Quality assurance or according to Annex VII Technical File Examination AND Annex V Production Quality Assurance.
Your opinion is appreciated

Thanks in advance
 

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Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Conformity Assessment Route according to Annex V only

There's no route of Annex V only. However, the drawing you attached is wrong.

The Annex VII route (declaration of conformity) is performed by the manufacturer, not the NB. The NB would only perform only Annex IV, V or VI, so you would only have a certificate for either of those.

Regarding the the analysis of the device design (Annex II - 4. Examination of the design of the product) it is only required for Class II devices, and you have to lodge a separate application (and you will have a separate certificate).

For other classes, the technical file is reviewed only to the extent of meeting the QMS requirements (for example, the requirements in item 3 of the Annexes-routes).
 
S

silentassassin

#3
Hi Marcelo,

Thanks for your response.
So as I understand from your explanation that a certificate issued according to Annex V is correct ? (see attachment)

Can provide me with some references further explaining this assessment routes
 

Attachments

Marcelo

Inactive Registered Visitor
#4
Hi Marcelo,

Thanks for your response.
So as I understand from your explanation that a certificate issued according to Annex V is correct ? (see attachment)

Can provide me with some references further explaining this assessment routes
See below:

Article 11
Conformity assessment procedures

2. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either:
(a) the procedure relating to the EC verification set out in Annex IV; or
(b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance);
or
(c) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
Please note that for Annex V, the manufacturer must "lodge an application for assessment of his quality system with a notified body", which in the end will give you the certificate for this Annex.

Annex VII does not have this requirement because the manufacturer himself performs the activity (including drafting the declaration of conformity that covers both annexes, as detailed in Annex VII 6.1.).
 

Marcelo

Inactive Registered Visitor
#5
Another thing - you as the manufacturer should have chosen the route you want between the 4 possible routes, so this should have been discussed in the beginning of the process. Did you not chose the route?
 
S

silentassassin

#6
Thank you for your feedback, much appreciated !
Well during the audit they insisted to certify us according to Annex V.
we still don't get why ?!?!
 

Marcelo

Inactive Registered Visitor
#8
One of the reasons may be that they sold you something and then noticed that another solution would be better (usually for them, because it may require less work and keep gaining the same amount).
 
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