News

We invite you to take a minute of your time to share your insights on the challenges you would like (...)

The European Commission published a flowchart allowing the manufacturers to determine whether their devices can benefit from the new transitional (...)

“RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of (...)

Have a look at our video to learn more about the value add and benefits our trainings can provide for (...)

Against the recent backdrop of regulatory updates and information for the UKCA marking, LNE-GMED UK has produced a short summary (...)

On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional (...)

The European Commission published a new EUDAMED user guide about the registration of certificates. The purpose of this user guide (...)

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

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

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)

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

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

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

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

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

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

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

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

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

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 (...)