A
Arnthor
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
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
Last edited by a moderator: