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MDCG 2022-9: Summary of Safety and Performance template under Regulation (EU) 2017/746
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a (...)
MDCG 2022-8: Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in (...)
MDCG 2022-7: Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-7 questions and answers on the Unique Device (...)
List of harmonized standards under Regulation (UE) 2017/745
For your information the European Commission has just published the implementing decision (UE) 2022/757 amending the list of harmonized (...)
List of harmonized standards under Regulation (EU) 2017/746
The European Commission has just published the implementing decision (EU) 2022/729 amending the list of harmonized European standards under (...)
Guidance MDCG 2022-6 on significant changes regarding the transitional provision under Article 110(3) of the IVDR
The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-6 which aim to provide clarification on (...)
Guidance MDCG 2022-5 on borderline between medical devices and medicinal products under Regulation (EU) 2017/745
The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation (...)
UKCA marking: Key steps to consider
The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom (...)
Newsletter on Medical Devices | European Commission – April 2022
This newsletter from the European Commission aims to provide highlights and updates from the medical devices sector. In this (...)
Revision of Guide MDCG 2019-9 Rev.1 on the summary of safety and clinical performance
The Medical Device Coordination Group (MDCG) has just published the updated Guide MDCG 2019-9 Rev.1. This March 2022 revision (...)
Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745
It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with (...)
GMED has certified its first in vitro diagnostic medical devices under Regulation (EU) 2017/746
GMED is pleased to announce that its team has issued its first certificates under the European In Vitro Diagnostic (...)
Amendment A11 of NF EN ISO 14971:2019 Standard
The amended standard NF EN ISO 14971 has been published in its December 2021 version. Added Annexes ZA and (...)
Transition to European Medical Device Regulation: Feedback and Challenges to be met
Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common (...)
MDCG Guidance 2022-2 on general principles of clinical evidence for In Vitro Diagnostic Medical Devices
The MDCG (Medical Device Coordination Group) has recently published the MDCG 2022-2 Guidance which outlines the general principles of (...)
Changes to medical device and/or quality management system: when and how to submit a request?
The purpose of the guide, prepared by GMED, is to clarify when and how to submit a change application (...)
The progressive implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices is officially adopted
Regulation (EU) 2022/112 of the European Parliament and of the Council has been published in the Official Journal of (...)
GMED recognized as a Notified Body partner in the new TCP III mutual recognition program (Taiwan)
GMED is one of the 6 Notified Bodies to have been recognized as a European Notified Body partner in (...)
Teresa Perry, Quality & Accreditation Director at LNE-GMED UK
David Francis, General Manager of LNE-GMED UK, a subsidiary of the LNE Group and a future UK certification body, (...)
MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
The Medical Devices Coordination Group (MDCG) has published the notice MDCG 2022-1 for manufacturers of in vitro diagnostic medical (...)
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 (...)
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 (...)
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 (...)
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 (...)
Best wishes 2022
GMED wishes everyone a happy new year 2022! Thank you to our customers for their trust, our partners for (...)
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 (...)
Biological evaluation: chemical characterization according to EN ISO 10993-18:2020
The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing (...)
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. (...)
Biological assessment of medical devices according to the ISO 10993-1 standard
The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation (...)
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 (...)