Inside Medical Technology

11 - 12 April 2018 // Nuremberg, Germany

This is what MT-CONNECT and MedTech Summit 2018 have to offer.

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MDR and IVDR: What do Manufacturers Need to Observe?

IVDR from the Manufacturer's Point of View Vortragssprache Deutsch Simultanübersetzung Englisch

The new European Regulation on in-vitro diagnostic medical devices has entered into force in May 2017 and introduced significant new challenges for the entire IVD industry. One of the most significant changes is the introduction of a new, rule-based classification system for IVD products which will force many existing products to go through CE certification with a Notified Body.

The new European Regulation on in-vitro diagnostic medical devices has entered into force in May 2017 and introduced significant new challenges for the entire IVD industry. One of the most significant changes is the introduction of a new, rule-based classification system for IVD products which will force many existing products to go through CE certification with a Notified Body. Aim of this presentation is to highlight key changes introduced by the European IVD Regulation and to outline their potential impact for IVD manufacturers and the IVD industry.

--- Date: 12.04.2018 Time: 9:50 AM - 10:15 AM Location: Hall Brüssel I, NCC Mitte

In cooperation with:

Bundesverband Medizintechnologie, BVMed

Speakers

 Tobias Bartl

Tobias Bartl

Regulatory Affairs Expert / CE plus GmbH

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