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LNE-GMED UK accredited for IVDs under ISO/IEC 17021-1:2015 standard
LNE-GMED UK, GMED subsidiary of the LNE group, has extended its accreditation by UKAS under ISO/IEC 17021-1:2015 for quality (...)
Guidance MDCG 2024-3 on content of the Clinical Investigation Plan for clinical investigations of medical devices
The Medical Device Coordination Group (MDCG) has published the MDCG 2024-3 guide regarding the content of the clinical investigation (...)
Periodic safety update reports for devices: requirements and feedback
The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of (...)
Update of the list of harmonised standards under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR)
The Commission Implementing Decisions (EU) 2024/815 and (EU) 2024/817 have been published in the Official Journal of the European (...)
GMED and LNE at Medi’nov
From April 3 to 4 at the Lyon Convention Center, join the GMED and LNE teams for the latest (...)
LNE-GMED UK is one of the founding members of Team-AB, the UK Association for Medical Device Approved Bodies
In the evolving regulatory context in Great Britain, a group of UK Approved Bodies formed “Team-AB” in February 2024. (...)
GMED at the MedTech Meetup
Meet our team at the 7th edition of the MedTech Meetup, on March 14 in Brussels. Hosted (...)
Publication of guidance MDCG 2024-1 and ancillary guidances MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, MDCG 2024-1-4
The Medical Device Coordination Group (MDCG) has just published new guidances that describe how to report to competent authorities (...)
LNE-GMED UK designated under UK Medical Devices Regulations 2002
LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has been designated as an Approved Body under (...)
Publication of tables summarising the language requirements applicable in each Member State
The European Commission has published on its website tables listing all the language requirements mentioned in Regulations (EU) 2017/745 (...)
1st revision of the guidance MDCG 2019-07 on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) regarding the ‘person responsible for regulatory compliance’ (PRRC)
The Medical Device Coordination Group (MDCG) has made several additions throughout the MDCG 2019-7 guidance, including on the qualifications, (...)
Happy New Year 2024
All the best for 2024! In this time of regulatory change, all of our teams would like to thank (...)
MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products
The Medical Device Coordination Group (MDCG) has published the MDCG 2023-6 guidance that is applicable to products without an (...)
MDCG 2023-5: Guidance on qualification and classification of Annex XVI products
The Medical Device Coordination Group (MDCG) has published the MDCG 2023-5 guidance that provides elements useful for the qualification (...)
LNE-GMED UK accredited under ISO/IEC 17021-1:2015 standard
LNE-GMED UK, GMED subsidiary of the LNE group, has just been accredited by UKAS under ISO/IEC 17021-1:2015 for quality (...)
Designation of European Union Reference Laboratories
The Official Journal of the European Union has published Implementing Regulation (EU) 2023/2713 designating European Union Reference Laboratories (EURLs) (...)
Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745
It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with (...)
Publication of Commission Regulation (EU) 2023/2482 of November 13, 2023
Commission Regulation (EU) 2023/2482 of November 13, 2023, amending Regulation (EC) No 1907/2006 (REACH) of the European Parliament and (...)
Combined audits MDD/AIMDD and MDR : requirements and impact on the quality management system
The date after which “legacy devices” can no longer be placed on the market or put into service pursuant (...)
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 (...)
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 (...)
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 (...)
Any certification projects?
The new regulatory deadlines open up new perspectives for marketing your medical devices in Europe, even for the most (...)
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 (...)