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European Commission Newsletter on medical devices | May 2023

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

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Newsletters

Article 61(10) of Regulation (EU) 2017/745: Instructions for use and FAQ

According to Article 2(44) of the Medical Devices Regulation (EU) 2017/745 (MDR), clinical evaluation is defined as a “systematic (...)

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The European Commission guidance on the content and structure of the summary of the clinical investigation report

On May 8, 2023, the European Commission has published its guidance on the content and structure of the summary (...)

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1st revision of the guidance MDCG 2020-3 on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) (...)

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Q&A on the practical implementation of Implementing Regulation (EU) 2023/607 amending the transitional provisions of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR)

The European Commission has published on the European Commission’s website a Q&A to facilitate the practical and homogeneous implementation (...)

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European Commission Newsletter on medical devices | March 2023

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

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MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 guide, which aims to clarify important terms and (...)

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Extension of transition period for medical devices and in vitro diagnostic medical devices adopted

The amendment that modifies Regulations (EU) 2017/745 and (EU) 2017/746 with respect to transitional provisions for certain medical devices (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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). (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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Newsletters

In vitro diagnostic software: Novelties introduced by Regulation (EU) 2017/746

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

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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 (...)

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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 (...)

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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 (...)

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