Meaning of Annex II, excluding point Clause 4 conformity

Harini17

Starting to get Involved
#1
Dear Experts,

It would be great if you could explain me what is the meaning of this:

Annex II, excluding point Clause 4 conformity assessment route of EC Council Directive 93/42/EEC, as amended by 2007/47/EC concerning medical
devices.


Why this needs to be included in the CERs?

Looking forward to hear from you soon.

Thank you
 

Harini17

Starting to get Involved
#3
Hi,

Thanks for your reply.

I was reading one of the CERs of Class II-b device, there I could see this information. When I saw this in MDD 93/42/ EEC Article 11 section 3 mentions the same. Is it important to include in the CER?

Also it would be great if you could clarify the inclusion of similar devices in the literature review section. I couldn't find the convincing answer for this from the Regulatory standpoint. Most of them say that we shouldn't include as we are not claiming equivalence with those devices and say it is only required for state of the art section. I have seen inclusion of similar device in many CERs. If you could answer this with relevant justification, it would be more helpful.

Looking forward to hear from you

Thank you
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
Hi,

Thanks for your reply.

I was reading one of the CERs of Class II-b device, there I could see this information. When I saw this in MDD 93/42/ EEC Article 11 section 3 mentions the same. Is it important to include in the CER?

No, this has nothing to do with the CER. It's only there (and 11 only details the conformity assessment routes) to define that "4. Examination of the design of the product"on Annex II is not applicable to class IIb devices if you follow 11.3.a).

Also it would be great if you could clarify the inclusion of similar devices in the literature review section. I couldn't find the convincing answer for this from the Regulatory standpoint. Most of them say that we shouldn't include as we are not claiming equivalence with those devices and say it is only required for state of the art section. I have seen inclusion of similar device in many CERs. If you could answer this with relevant justification, it would be more helpful.
You can include similar devices (which are not equivalent) for several reasons, as listed in the MEDDEV MEDDEV 2.7/1 revision 4, 9.3.2 b).

However, you cannot use similar, non-equivalent device data to demonstrate conformity with ERs.

I have seen inclusion of similar device in many CERs.
I've also seen that in several CERs, but the point is that they are wrong. If reviewed under MEDDEV MEDDEV 2.7/1 revision 4, those should not be acceptable.
 

Harini17

Starting to get Involved
#5
Thank you so much for your clarifications/answers not only this for many of my questions till now. It really helps learners like me, who are in search of answers from the Regulatory standpoint.
:thanx:
Best,
 

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