Declaration of Conformity acording to the ZLC 3.9 A4 Conformity Assessment

#1
Hi Mates,

According to the ZLC 3.9 A4 Conformity Assessment - Declaration of Conformity is documented that required 1st lot number affix CE Mark which put into the market. This was also required by our NB's auditor.

I am doubtful on the wording "MARKET"... is that must be the 1st lot of our products put into EU market??? As sometimes, like my small company obtaining CE Mark but our products yet emerged into EU market. In this case, what is the lot # shall i put??

Tiff
:bonk:
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#2
Re: Declaration of Conformity

Not sure which document you are mentioning but please analyse the definitions below:

The 'placing on the market' is defined as "the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished' (Article l(2)(h) Directive 93/42/EEC; Article l(2)(h) Directive 90/385/EEC).

The 'putting into service' is defined as "the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose" (Article l(2)(i) Directive 93/42/EEC) or as the "making available to the medical profession for implantation" (Article l(2)(g) Directive 90/385/EEC), respectively.
 
#3
Re: Declaration of Conformity

It is a ZLG Answer & Resolutions EK-MED with the Doc # 3.9A4.

Was it mean that we need to put in the 1st lot # applying CE Mark where these products put into EU Market?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#4
Re: Declaration of Conformity

Ok, i think maybe you are confusing some things.

The medical devices directives requires that you have a CE mark (and the declaration of conformity is the "legal" document which make you give yourself the CE mark) before putting devices into market ("the first making available in return for payment or free of charge of a device.....) in the EU.

All your devices must bear CE marking.

If your CE Marking refers to a batch, lot, etc, you must declare which ones in your DOC. Another way is to have a validity period for the declaration of conformity, so all your lots on the period would have CE mark. But you still need to affix the CE marking in all of them.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#5
Re: Declaration of Conformity

I am doubtful on the wording "MARKET"... is that must be the 1st lot of our products put into EU market??? As sometimes, like my small company obtaining CE Mark but our products yet emerged into EU market. In this case, what is the lot # shall i put??
If i understand what you said, i think you are doing something against the law (putting on the market devices which need CE marking without them already being CE marked).
 
#6
Re: Declaration of Conformity

May be I need clarify to you that the products have obtaining the CE Mark and was audited since 2006. The products first obtained since Aug 2006 but during that time yet putting product into EU, it happened to go into EU market after a year obtaining CE Mark.
 
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