Quote:
In Reply to Parent Post by Norman Bass
Mycompany is the only manufactor of Nebulizer in US.
IT is a class 2a -what is best route to geting CE mark?
Directives
EU LAB
Authoried Rep.
 Norman Bass |
Hi Norman Bass
I am not familiar with your product indented use/product claim. From the information provided in above, I understand that your product is fall under the category of
class IIa as per European Medical Devices Directive 93/42/EEC.
There are two alternatives routes are available to the manufacturer for class IIa devices (other than those that are custom made or intended for clinical investigation).
The first option is for Full Quality Assurance System assessment (Annex II, except for Section 4).
The second option is for the EC Declaration of Conformity (defined in Annex VII), coupled with either the procedure relating to EC Verification (Annex IV), the procedure relating to the EC Declaration of Conformity (Production Quality Assurance, Annex V) or the procedure relating to the EC Declaration of Conformity (Product Quality Assurance, Annex VI).
Please refer attached conformity assessment route for class IIa product.
Regards
S. Subramaniam
Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark?
I read this and found it most helpful. I already had the document in my files but knowing the exact page to go to helped. 
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