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31 March - 2 April 2020 // Nuremberg, Germany

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Exhibitors & Products MedtecLIVE 2019
Zoom product LOGO_Market authorization in Europe

Market authorization in Europe

LOGO_Market authorization in Europe

Market authorization in Europe

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From the classification to CE-certification

confinis has extensive experience in developing sound, regulatory compliant strategies for attaining CE-certification, which is necessary for the introduction of medical devices in the European Union. The specific requirements also depend on the classification of the respective products.

We will gladly support you from determining the classification of your medical devices or in-vitro diagnostics under the new European Medical Device Regulation 2017/745, help you throughout the compilation of the required certification documentation, handling interactions with your Notified Body up to the product launch in the EU.

Market authorization in Europe is assigned to following product groups:

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