Declaration of conformity
The manufacturer, or his EU authorised representative established, is obliged to issue an EU Declaration of Conformity that the product is in a conformity assessment procedure required by the directive on medical devices before being placed on the market. With the Declaration of Conformity the manufacturer declares that the products concerned meet the relevant provisions of the applicable directives or the type described in the type examination certificate, respectively. The content of the EU Declaration of Conformity is determined in each directive.
The declaration of conformity according to directive 93/42/EEG should contain at least the following contents:
the name and address of the manufacturer or his authorised representative
where procedures according to Annex II or VII in connection with IV, V or VI are applied, the obligation to draw up the declaration of conformity lies exclusively with the manufacturer (see e.g. 93/42/EEG appendix VII Abs. 6.1).
- the EU Directive(s) and their Annexes, after which the conformity is declared
- a statement that the manufacturer is exclusively responsible for the declaration of conformity
- object of the declaration: data about the product (name, design/type or model number)
- number of products the declaration of conformity refers to (e.g. lot, batch, or serial numbers, numbers of items). As an alternative to the indication of lot, batch or serial numbers, the clear reference to the products covered by the declaration of conformity can be established via the validity period of the declaration of conformity, which is limited by the issuing of a revised declaration of conformity after change in the product and/or by the expiry date of the certificate(s) issued by the notified body.
- additional information (e.g. applied standards, normative documents)
optionally; if standards are referenced, all applicable parts of the standards must be fulfilled
- place and date of the declaration of conformity
- legally-binding signature and function of the authorised person
- name, address and identification number(s) of notified bodies being involved in the conformity assessment procedure
If several EU-Directives are applicable in parallel, it must be recognizable which notified body is assigned to which directive. If the conformity assessment presupposes the engagement of more than one notified body in the production phase or, if required by the directives, the CE-Marking on the product shall be followed by the identification numbers of these bodies.