News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary (...)

Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular (...)

The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-7 questions and answers on the Unique Device Identification (...)

For your information the European Commission has just published the implementing decision (UE) 2022/757 amending the list of harmonized European (...)

The European Commission has just published the implementing decision (EU) 2022/729 amending the list of harmonized European standards under Regulation (...)

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-6 which aim to provide clarification on the (...)

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation between (...)