Knowledge Center

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application (...)

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro (...)

Dr Duncan McPherson, who recently joined LNE-GMED UK as internal clinician, has been appointed as a member of the (...)

The European Commission has adopted a proposal for a regulation amending the transitional provisions of Regulations (EU) 2017/745 and (...)

3, 2, 1… Happy New Year! From Paris to Washington D.C. through London, the GMED group teams line up (...)

The Medical Device Coordination Group (MDCG) has published the MDCG 2022-21 guidance on the Periodic Safety Update Report (PSUR). (...)

The working group on “Borderline and Classification” has just made available on the European Commission website the 2nd version (...)

During the Council of the European Union meeting on December 9, 2022 devoted to the Employment, Social Policy, Health (...)

LNE-GMED UK is pleased to welcome Dr Duncan McPherson as Internal Clinician. Dr Duncan McPherson has a BSc degree (...)

GMED informs you that its teams have just certified under Regulation (EU) 2017/746 the first four Class D in (...)

The Medical Devices Coordination Group (MDCG) sets out in document MDCG 2022-17 its position on the possible use of (...)

The European Commission has adopted the Implementing Regulation (EU) 2022/2347 reclassifying certain active products listed in Annex XVI of (...)

Implementing Regulation (EU) 2022/2346 establishing the Common Specifications (CS) for the groups of products without an intended medical purpose (...)

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2022-16 for authorized representatives, manufacturers, and other economic (...)

GMED has extensive experience with a team specialized in assessing medical devices incorporating medicinal substances under Regulation (EU) 2017/745 (...)

On 21st October 2022, the Medicines & Healthcare products Regulatory Agency (MHRA) has just informed the industry stakeholders of (...)

The MDCG (Medical Devices Coordination Group) published the guidance MDCG 2022-15 on the appropriate surveillance to be conducted by (...)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties (...)

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro (...)

We are pleased to announce that Ava Sainter has joined our LNE-GMED UK subsidiary as an in vitro diagnostic (...)

The Borderline and Classification Working Group has just published on the European Commission website the Manual on borderline and (...)

GMED (CE 0459) is pleased to inform you about its evolution of scope of its designation as a Notified (...)

We are pleased to announce that Emma Raines has joined our subsidiary LNE-GMED UK as Certification Project Manager. With (...)

The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-12. This guidance is intended to enable Member (...)

On 26th June 2022, the UK Government outlined the results on the consultation on the future regulation of medical (...)

This special July edition is dedicated to two publications from June and the EPSCO (Employment, Social Policy, Health and (...)

In order to provide appropriate provisions regarding Class D in vitro diagnostic medical devices, the European Commission has adopted (...)

The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III (...)

In order to provide the necessary modalities as mentioned in Article 100 of the Regulation (EU) 2017/746 concerning the (...)

This Q&A intends to clarify certain interfaces between both following regulations: the Regulation (EU) No 536/2014 on clinical trials (...)