News
New harmonized European standards under Regulation (EU) 2017/746
The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/15 which amends (...)
New harmonised European standards under Regulation (EU) 2017/745
The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/6 which amends (...)
MDCG 2021-28: Model notification form for substantial modification of clinical investigation under Medical Device Regulation (EU) 2017/745
The sponsor of a clinical investigation is required to notify the Member States in which a clinical investigation is or (...)
Instructions for Electronic use of medical devices: Publication of the Implementing Regulation (EU) 2021/2226 in the OJEU
On December 15, 2021, the European Commission published in the Official Journal the Implementing Regulation (EU) 2021/2226 on rules for (...)
Best wishes 2022
GMED wishes everyone a happy new year 2022! Thank you to our customers for their trust, our partners for their (...)
EUDAMED: The Official Journal of the European Union has published the commission implementing regulation (EU) 2021/2078
On November 29th, 2021, the European Commission published in the Official Journal the commission implementing regulation (EU) 2021/2078 laying down (...)
Creation of LNE-GMED UK subsidiary: LNE group increases its international presence
The LNE group is expanding its certification activities in the UK by setting up a new subsidiary: LNE-GMED UK. The (...)
The European Commission proposes a gradual implementation of the European Regulation on in vitro diagnostic medical devices
The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic operators (...)
MDCG 2021-24 Medical Device Classification Guidance
The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-24 guide. This document is intended to help manufacturers (...)
On November 16th, GMED is organizing its IVDMD Forum: Implementation of Regulation (EU) 2017/746
This new digital edition will bring together on a TV studio our speakers who will address several topics including the (...)
EUDAMED: New modules available
The modules: “Unique Device Identification (UDI)” and “Notified Bodies & Certificates” are now available in EUDAMED. Economic operators and notified (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)