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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 (...)
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 (...)
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 (...)
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 (...)
Clinical evaluation: the strategic path of Well Established Technologies (WET) for legacy devices
Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
Publication of EUDAMED user guides
The European Commission published a new EUDAMED user guide about the registration of certificates. The purpose of this user (...)
Clinical evaluation: Feedback and good practices
Regulation (EU) 2017/745 (MDR) puts the patient at the center of its scope. This is an important development to (...)
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 (...)
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 (...)
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 (...)
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) (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
Best wishes 2023
3, 2, 1… Happy New Year! From Paris to Washington D.C. through London, the GMED group teams line up (...)
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). (...)
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 (...)
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 (...)