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MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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

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European Commission Newsletter on medical devices | December 2022

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

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Dr. Duncan McPherson appointed to WHO expert group on medical devices

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

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Proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746

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

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Best wishes 2023

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

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MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)

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

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Version 2 – Manual on borderline and classification for medical devices under Regulations (EU) 2017/745 and (UE) 2017/746

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

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Communication on the draft amendment for the postponement of the EU MDR application date

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

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Dr Duncan McPherson, Internal Clinician, LNE-GMED UK

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

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GMED certifies its first class D in vitro diagnostic medical devices under Regulation (EU) 2017/746

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

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MDCG 2022-17: MDCG position paper on hybrid audits

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

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Implementing Regulation (EU) 2022/2347 laying down rules for the application of Regulation (EU) 2017/745 as regards reclassification of groups of certain active products without an intended medical purpose (Annex XVI)

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

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Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose (Annex XVI)

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

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Guidance MDCG 2022-16 on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

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

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Your certification projects for medical devices incorporating a medicinal substance under Regulation (EU) 2017/745

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

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Current MHRA position regarding transitional requirements to the future regulation of medical devices in the United Kingdom

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

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Guidance MDCG 2022-15 on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

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

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European Commission Newsletter on Medical Devices | September 2022

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

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Ava Sainter, IVD Product Reviewer, LNE-GMED UK

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

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Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

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

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New sterilization methods in the GMED’s designation scope under Regulation (EU) 2017/745

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

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Emma Raines, Certification Project Manager, LNE-GMED UK

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

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MDCG 2022-12: Harmonization of administrative practices and alternative technical solutions prior to full functionality of Eudamed under Regulation (EU) 2017/746

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

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Current position of LNE-GMED UK after first review of the consultation on the future regulation of medical devices in the United Kingdom

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

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Implementing Regulation (EU) 2022/1107 laying down common specifications for Class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746

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

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Implementing Regulations (EU) 2022/944 and (EU) 2022/945 laying down detailed rules for the implementation of Regulation (EU) 2017/746 regarding EU Reference Laboratories

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

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MDCG 2022-10: Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

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

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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 summary (...)

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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 particular (...)

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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 Identification (...)

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