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What does CE marking mean for medical device manufacturers?

The CE mark stands for "Conformité Européenne" which means "European Conformity". By CE marking the manufacturer declares the conformity of his medical device, in-vitro diagnostic medical device or active implantable medical device with the relevant directives MDD 93/42/EEC, IVDD 98/79/EEC and AIMDD 90/385/EWG of the European Community. Prior to CE marking a conformity assessment described in the directives must be completed for each device.

Only medical devices or in-vitro diagnostic medical devices within the scope of these directives can be CE marked. CE marking must not be applied to products that do not fall under the directives.

Once a medical device is CE marked - either by self-declaration for class I medical devices or in cooperation with your Notified Body for devices classes Is, Im, IIa, IIb, III or AIMD - sales in Europe is allowed after CE registration with the relevant competent authorities. MedNet as your EC Representative will perform this national product registration as part of our Authorized Representation Services.

What are Notified Bodies? How can I find one?

Notified bodies are appointed by each member state of the European Community under the appropriate national regulations to conduct third-party conformity assessment procedures to the relevant medical device or its production processes, as required by the directives, in order that it may be CE marked. The CE conformity procedures vary according to the directives, and third-party involvement is not obligatory for all medical devices. Manufacturers can use the services of Notified Bodies in any member state of the European Community.

Are there any regulations about the appearance of the CE-mark?

According to the directives, the CE marking of conformity, as shown e.g. in Annex XII of the medical device directive 93/42/EEC, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, as well as on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging. It shall be accompanied by the identification number of the notified body responsible, if applicable.

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