ce marking
Conformite Europeenne Marking
To export medical devices into the European Community, the device must
display 'CE' Marking. 'CE' marking is an indication that the device has
undergone some form of third party verification and validation process
acceptable to the EEC. For Medical devices these processes are taken
from one or more of the 12 annexes that are described in the Medical
Device Directives which include:
MDD annex V - EC declaration of Conformity
"Verification of the Quality Management System that produced the device"
MDD annex III - CE Type-Examination.
"Determining that the device meets the functional claims of the
manufacturer, including any related safety and EMC tests"
Successful compliance to both of these annexes would allow the 'CE'
marking to be attached.
The CE marking requirements consist of 3 parts, all of which must be
satisfied. These are:
* The affixing of the mark;
* The drawing up of and EC Declaration of Conformity;
* Compiling and holding the Technical Documentation.
CE Marking
CE marking is a visible declaration by the manufacturer or his
authorized representatives that the product satisfies all the provisions
of the related Directives).
You should note that the 'Manufacturer" is clearly defined in the
Directive.
Equipment bearing CE Marking will be taken as meeting the requirements
and thereby entitled to free circulation throughout the EEA provided
that the equipment does in fact satisfy those requirements.
By affixing CE marking to equipment, the manufacturer is making a
statement that his equipment meets the requirements of all relevant
Directives. It is for the manufacturer to decide which other Directives
are relevant to his equipment.
EC Declaration of Conformity
An EC Declaration of Conformity is a written declaration by the
manufacturer or his authorized representative that the equipment to
which the CE marking has been affixed complies with the requirements of
the related Directives).
Technical Documentation
The Technical Documentation provides the enforcement authorities with
the means of assessing the conformity of the equipment to the
requirements of the related Directives).
A comprehensive list of requirements to be included in the Technical
File can be found on this web site. The Documentation does not have to
be assessed by an approved body but it must be possible to assemble it
whether or not the equipment has undergone any independent testing,
certification, or approval. It must be kept for a period of not less
than 5 years after manufacture of the equipment to which it relates has
ceased.
AQAS is familiar with the 'CE' and MDD requirements and can take your
company through the processes - painlessly !
Note the CE Directive 93/68/EEC affects other EEC Directives as
followings:
CE Directive Affects
Directive 93/68/EEC
Council Directive amending Directives :
87/404/EEC, 88/378/EEC, 89/106/EEC, 89/336/EEC,
89/392/EEC, 89/686/EEC, 90/384/EEC, 90/385/EEC,
90/396/EEC, 91/263/EEC, 92/42/EEC , 73/23/EEC
E-mail: sales@aqas.com.au