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Appointment of expert panels by the European Commission

The European Commission has just appointed expert panels in the field of medical devices and in vitro diagnostic medical devices (...)

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GMED Newsletter : Qualification and Classification of Medical Device Software under Regulation (EU) 2017/745

Last October, when our website was launched, you discovered our new Knowledge Center, centralizing our news, guides and webinars. Today, (...)

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Publication of a Team-NB position paper on changes affecting the device component of a drug device combination under Article 117 of the Medical Device Regulation (EU) 2017/745

Team NB has published on its website a position paper about substantial changes impacting the device component of a drug (...)

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Best wishes 2021

It is a particular and unprecedented year which has just ended…The mobilization and adaptability of all have made it possible (...)

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MDCG summary document on UDI assignment for Spectacle lenses & Ready readers

The Medical Device Coordination Group (MDCG) has just published a summary document on the UDI assignment (Unique Device Identifier) for (...)

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EUDAMED: Launch of the economic actors’ registration module

The European Commission has recently rolled out the first EUDAMED module called “Actor registration module” and intended for economic operators: (...)

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Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

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European Commission publication on EUDAMED and the module on economic actors’ registration

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

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The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

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The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)

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MDCG Position paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)

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European Commission updated FAQs on Unique Device Identification (UDI)

The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)

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Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure

The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)

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GMED designated under Regulation (EU) 2017/745 on medical devices

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency (...)

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