News
LNE-GMED UK: successful final step before designation under the UK Medical Devices Regulations
After a favorable MHRA audit, LNE-GMED UK, subsidiary of the GMED Group, is now in the final stages of obtaining (...)
LNE-GMED UK celebrates 1 year as a UK Approved Body!
After obtaining UKAS ISO/IEC 17065:2012 accreditation, LNE-GMED UK (part of LNE Group) was originally appointed by the UK Government Department (...)
MDCG 2023-4: Guidance on Medical Device Software (MDSW) – Hardware combinations
The Medical Device Coordination Group (MDCG) has published the MDCG 2023-4 guidance on MDSW intended to work in combination with (...)
Any certification projects?
The new regulatory deadlines open up new perspectives for marketing your medical devices in Europe, even for the most innovative (...)
Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of Regulation (EU) 2017/745
The European Commission has published a Q&A on the transitional provisions applicable to products without an intended medical purpose covered (...)
European Commission Newsletter on medical devices | September 2023
This newsletter from the European Commission aims to provide highlights and updates from the medical devices (MDs) and in vitro (...)
Andrew Bailey, Product Reviewer for Orthopaedic Implants, LNE-GMED UK
We are pleased to announce the arrival of Andrew Bailey to our subsidiary LNE-GMED UK, in the position of Product (...)
Keeping pace with our growth, we’re moving to a new office
As part of the GMED Group’s expansion, GMED North America is excited to announce that we have relocated our office (...)
Our priority at GMED North America’s Training Center is to deliver the trainings you need!
We invite you to take a minute of your time to share your insights on the challenges you would like (...)
Conditions and deadlines for placing ‘legacy devices’ and class III custom-made implantable devices on the market or putting them into service in accordance with Article 120 (EU) 2017/745, as amended by Regulation (EU) 2023/607
The European Commission published a flowchart allowing the manufacturers to determine whether their devices can benefit from the new transitional (...)
RAPS Convergence 2023 | Oct. 3-5 – Montreal, QC
“RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of (...)
How to address your challenges with our trainings
Have a look at our video to learn more about the value add and benefits our trainings can provide for (...)
Summary of UKCA timeline changes
Against the recent backdrop of regulatory updates and information for the UKCA marking, LNE-GMED UK has produced a short summary (...)
Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional (...)
Publication of EUDAMED user guides
The European Commission published a new EUDAMED user guide about the registration of certificates. The purpose of this user guide (...)
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 diagnostic (...)
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 of (...)
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) 2023/607 (...)
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 of (...)
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 diagnostic (...)
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 concepts (...)
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 (MD) (...)
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 (...)
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 (...)
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 (...)
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 (...)
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) (...)
Best wishes 2023
3, 2, 1… Happy New Year! From Paris to Washington D.C. through London, the GMED group teams line up today (...)
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 (...)
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 (...)