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Expert panels for IVDMDs

The European Commission’s website indicates that the expert panels for in vitro diagnostic medical devices is now accepting submissions from (...)

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MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

The Medical Device Coordination Group has published the MDCG 2021-23 guidance. This guidance is intended to provide assistance to notified (...)

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News

Publication of the MDCG 2021-22 Guidance

The Medical Device Coordination Group has just published the MDCG 2021-22 guide regarding the clarification on “the 1st certification for (...)

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News

First lists of harmonized European standards under the European Regulations on MDs and IVDs

The European Commission has published in the Official Journal of the European Union, the list of the first harmonized European (...)

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MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

The Medical Device Coordination Group has just published the MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic (...)

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GMED designated under Regulation (EU) 2017/746 on in vitro diagnostic medical devices

GMED (CE 0459) has just been designated as a Notified Body under Regulation (EU) 2017/746 by the French National Agency (...)

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Guides

Application request for CE marking certification – Regulation (EU) 2017/746

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

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News

MDCG 2021-14 : Explanatory note on IVDR codes

The Medical Devices Coordination Group (MDCG) has just published an explanatory note regarding code assignment under Regulation (EU) 2017/746. The (...)

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News

Guidance Note on Integrating UDI into an Organization’s Quality Management System

The Medical Device Coordination Group has just published guidance note MDCG 2021-19 on integrating UDI -within an organization’s quality management (...)

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News

Revised Q&A on registration of “other” actors in EUDAMED

The Medical Device Coordination Group (MDCG) has just revised the MDCG 2021-13 Guidance published last June by adding a 9th (...)

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Newsletters

The Post-Market Clinical Follow-up (PMCF) requirements under the European Medical Device Regulation: Step by Step PMCF

The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. (...)

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News

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices

The objective of this document is to identify the priority actions to be implemented in order to meet the requirements (...)

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Questions & Answers from the European Commission on the European Medical Device Nomenclature (EMDN)

The European Commission has just published a document gathering questions and answers on the EMDN. In accordance with Article 26 (...)

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News

FAQ on the European Medical Device Nomenclature (EMDN)

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-12 FAQ on medical devices and in vitro diagnostic (...)

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News

English version of the European Medical Device Nomenclature (EMDN)

A public consultation was organized by the European Commission on the European Nomenclature of MDs and IVD MDs (EMDN) within (...)

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News

MDCG 2021-08 Guidance on Clinical Investigation Application and Notification Documents

Medical Devices Coordination Group (MDCG) has published a guidance on clinical investigation Application and Notification documents. The sponsor of a (...)

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News

European Commission factsheet for manufacturers of implantable medical devices

Are you a manufacturer of implantable medical devices? Everything you need to know about the implant card and the information (...)

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Newsletters

Introduction to the Regulation (EU) 2017/746

The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)

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News

Launch of the Unique Device Identification (UDI) Helpdesk

On May 17, 2021, the European Commission launched a new helpdesk to assist economic operators in the implementing the obligations (...)

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News

Harmonized European Standards under the European Regulations on MD and IVD MD

On May 12, 2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) formally informed (...)

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News

MDCG 2021-5 Guidance on standardisation for medical devices

The Medical Devices Coordination Group (MDCG) has just published guidance on standardisation for medical devices. The aim of this document (...)

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News

Factsheet of the European Commission of Class I medical devices under Regulation (EU) 2017/745

Are you a manufacturer of Class 1 medical devices? What you need to know about Regulation (EU) 2017/ 745 is (...)

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News

Publication of a new revision (rev. 4) of the MDCG 2018-1 Guidance on basic UDI-DI and changes related to UDI-DI

In the MDCG 2018-1 Rev. 4 Guidance, the definition of the basic UDI-DI has been revised by deleting the concept (...)

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News

Certification process for SARS-CoV-2 self-tests

In the context of the health crisis, the French and European authorities have authorized a derogation for the placing on (...)

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Newsletters

Clinical evaluation in the era of Regulation (EU) 2017/745

In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

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News

MDCG Infographic “Is your software a medical device ?”

The European Commission has just published the infographic titled “Is your software a medical device?” This infographic outlines the main (...)

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News

Publication of a European Commission guide on the management of Legacy Devices in EUDAMED

The European Commission has published a guide on the management of Legacy Devices in EUDAMED. Legacy devices are defined as (...)

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News

MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

The European Commission has just published the Guidance MDCG 2021-1. This document intends to describe harmonized administrative practices and alternative (...)

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News

GMED has certified its first medical devices under Regulation (EU) 2017/745

GMED is pleased to announce that its team has issued its first certificates under the European Medical Device Regulation. Since (...)

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Newsletters

MDSAP Program: Principles, Implementation and Advantages

The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)

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