Knowledge Center

After a favorable MHRA audit, LNE-GMED UK, subsidiary of the GMED Group, is now in the final stages of (...)

After obtaining UKAS ISO/IEC 17065:2012 accreditation, LNE-GMED UK (part of LNE Group) was originally appointed by the UK Government (...)

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-4 guidance on MDSW intended to work in combination (...)

The new regulatory deadlines open up new perspectives for marketing your medical devices in Europe, even for the most (...)

The European Commission has published a Q&A on the transitional provisions applicable to products without an intended medical purpose (...)

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

We are pleased to announce the arrival of Andrew Bailey to our subsidiary LNE-GMED UK, in the position of (...)

As part of the GMED Group’s expansion, GMED North America is excited to announce that we have relocated our (...)

Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. (...)

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

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

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

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

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

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

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

Regulation (EU) 2017/745 (MDR) puts the patient at the center of its scope. This is an important development to (...)

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

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

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

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

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

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

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

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

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

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 (...)