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Medical Devices Services

Medical Devices Services

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The Regulation 745/2017 defined as Medical Device any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or for specific medical purposes.

The Regulation (EU) 2017/745 

The Regulation (EU) 2017/745 introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device, deeply modifying the European legal framework for medical devices.

The MDR applies from 26 May 2021, following a four-year transition period. This means that manufacturers must comply with the Regulation when placing new medical devices on the market from 26 May 2021.

Medical Devices Classification

For a correct classification of Medical Devices, it is advisable to check the intended use and the mechanism of action. Medical Devices are classified into risk classes according to duration, mode and type of interaction with the body:

Main regulatory references for the European market:

Mérieux NutriSciences - Medical Devices

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Our Services

Thanks to a valuable pool of experts, Mérieux NutriSciences supports you in the development of the testing plan to determine which studies are necessary to ensure that the device is safe and effective, meeting the essential requirements for affixing the CE mark on the product.

Regulatory support and Risk Assesment

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Quality Controls and Stabilty

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Biocompatibility

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Adsorption and efficacy studies

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