CE Marking - Annex II Requirements for Class IIa Medical Device

A

Arnthor

#1
Dear all,

My company is going to apply CE marking for a Class IIa device and my boss plan to use Annex II to get the CE marking.

I understand that for a Class IIa and class IIb device using Annex II, it will be exempted from "EC design Examination".

Is the "EC design Examination” refers to "4. Examination of the design of the product" of the Annex II?

Am I right to say that for a class IIa device using Annex II, I do not have to describe the design, manufacture and performances of the product?

Or anything that is mentioned in “4. Examination of the design of the product" of the Annex II?

Any advice is greatly appreciated.

Best regards,

Arnthor
 
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pkost

Trusted Information Resource
#2
Re: CE Marking for Class IIa device

Hi,

When using Annex II, for a class IIa (or b) device all that is reviewed by your notified body is the technical file. The design dossier review is limited to class III devices only.

This can be seen in section 7:
7.1. In line with Article 11(2) and (3), this Annex may apply to products in
Classes IIa and IIb. Section 4, however, does not apply.
Although you don't have to submit the design dossier for review by the notified body, it is still a requirement that you carry out and document the design process. Although not part of the technical review, your ISO 13485 audits will examine the design aspects.

Hope this helps
 
A

Arnthor

#3
Re: CE Marking for Class IIa device

Hi,

Thanks for the reply.

Are you saying in the CE marking conformity assessment procedure my class IIa device is exempted from design process.

But in ISO 13485 cerification I will need to show the auditor my design input, output, vertification and validation report?

Please correct me if I am wrong.

Best regards,

Arnthor
 

pkost

Trusted Information Resource
#4
Re: CE Marking for Class IIa device

You are never exempted from the design process. Even a class 1 has to go through the process

I'm not saying you have to show the design file in a 13485 audit either. I'm just saying that as 13485 requires documentation and records from the design process, it is a request that the auditor can be expected to make. They may however chose a different design project to examine
 
#5
To use annex 11 your Design Control procedures must have been included in your 13485 audit, so making your system a "Full quality assurance system" (annex 11 title). And you must have the documentation to show that such design control procedures were followed.

If you don't have such procedures already in place it can be very difficult to achieve after the design has been completed. In such cases the Annex 5 plus Annex 6 route could be much simpler.
 
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