Conformity Assessment choices for a Contract Manufactured Class IIa Medical Device

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endlesslovehv

#1
What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer?
 
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bio_subbu

Super Moderator
#2
Re: Conformity assessment choices for a contract manufactured Class IIa device

What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer?
There are two choices for class IIa) products,

1. Annex VII (EC declaration of conformity and availability of technical documentation for authorities)

2. Annex II ( Full Quality Assurance system)

I request you to refer the existing thread “Conformity Assessment Route from the Medical Devices Directive (93/42/EEC) Help
 
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