CAP for Medical Device Class Is product - Slightly confused - ISO 13485

C

Camille

#1
First of all: My understanding is, that a class Is product would normally go the route according to Annex VII.

Situation:

- A product is classified as a class Is device
- The ISO 13485 certificate states:

  • several products (sterile and non sterile)

  • Annex II (except 4) and Annex V sterility aspects only.
- The class Is product should be reclassified as a IIb product based on indication extension


Does this mean that

a) the combination of Annex II and Annex V covers a class Is device?
b) the Annex II and V overrule Annex VII in this case?

I am a little confused :confused:

Thanks for your help :thanx:
 
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R

Roland Cooke

#2
Re: CAP for class Is product - Slightly confused

First of all: My understanding is, that a class Is product would normally go the route according to Annex VII.

Situation:

- A product is classified as a class Is device
- The ISO 13485 certificate states:

  • several products (sterile and non sterile)

  • Annex II (except 4) and Annex V sterility aspects only.
- The class Is product should be reclassified as a IIb product based on indication extension


Does this mean that

a) the combination of Annex II and Annex V covers a class Is device?
b) the Annex II and V overrule Annex VII in this case?

I am a little confused :confused:

Thanks for your help :thanx:
I'm confused as well!

The ISO 13485 certificate states:

several products (sterile and non sterile)
Annex II (except 4) and Annex V sterility aspects only.
Firstly, there is no direct relationship between your ISO13485 certificate and your MDD certificate. Classes of products are not described within ISO13485 so I will be surprised if your 13485 certificate actually says what you indicated.

As for your Class I sterile devices (under the MDD), you are correct that have to follow Annex VII (as with all Class I devices), however section 5 requires you to follow additional rules - which is where additional compliance to the relevant sections of Annex V kicks in.

When the revision of the MDD comes into force in 2010 you will also have the option to have your Class I (sterile) devices covered by Annex II.
(In hindsight the original official position of not allowing the use of Annex II was seen to be pointless, and probably counter-productive).



The class Is product should be reclassified as a IIb product based on indication extension
I'm not clear on what the context of this statement is.

Did you advise your Notified Body that you will be changing the intended use, and they in turn confirmed that that will cause the classification to go to Class IIB (for which Annex VII + V will no longer be appropriate)?

Or did you already change the intended use of the device (and maybe placed the device on the market), whilst still (mis)classifying it as Class I (sterile), which presumably resulted in a non-conformity being raised?
 
C

Camille

#3
Re: CAP for class Is product - Slightly confused

Sorry, for the confusion. My typo. I meant the MDD certificate :)

I understand that as a class IIb device Annex VII or V will no longer be appropriate. It would be either the Full Quality Assurance route according to Annex II or the EC Type Exam according to Annex III followed either by Annex IV, V or VI

BTW: The device is not yet placed on the market

Thanks for your help and input!
 
R

Roland Cooke

#4
Re: CAP for class Is product - Slightly confused

Annex III is typically only appropriate if
a) there is a full international standard that describes your products.
b) the tests described within the standard can be performed in-house or at a qualified laboratory (or equivalent situation)
c) it is economically worthwhile

Probably only 0.01% of medical devices utilise Annex III.....
 
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