Creation of GMED SAS: LNE subsidiaries its medical certification activity

Over the past five years, the certification of medical devices has undergone a real upheaval. The growth in normative and regulatory requirements has led to a significant increase in the tasks of notified bodies in Europe. The new European regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDD), which are due to be implemented in 2020 and 2022 respectively, set high standards for the quality and safety of medical devices. These new rules will require additional assessments by notified bodies, in particular in the context of technical documentation and post-market activities.

LNE, the only French notified body for the certification of medical devices through its GMED brand, meets these new requirements by adapting its organisation, while offering its customers the same high standards and quality of support that it has maintained for 20 years in the certification market.

LNE, an industrial and commercial public institution (EPIC), has thus made the choice to spin off this activity in order to develop and strengthen it in a demanding and fast-growing market requiring ever faster responses. The filialization of GMED should make it possible to better serve its customers, medical device manufacturers, in a context of major normative and regulatory changes, in the service of the health of our fellow citizens and the competitiveness of our industry.

Previously a pole within the LNE's Certification Department, GMED become, as of August 1, a wholly-owned subsidiary of LNE in the form of a simplified joint-stock company (SAS).

 

By giving GMED the opportunity to develop, gain flexibility and be more responsive while maintaining the high standards and excellence that have made it famous internationally, the LNE group is once again demonstrating its ability to adapt to better support the industry and the health of our fellow citizens.

Thomas Grenon, General director of LNE

 

Through this spin-off, GMED will gain in flexibility, autonomy, reactivity and agility; it will also be able to finance its growth more easily. The GMED is embarking on a new dynamic that will enable it to reduce the qualification times of its employees, to build their loyalty and to recruit more easily. In anticipation of this spin-off, GMED's workforce has already increased by 20% since the beginning of 2018.

Lionel Dreux takes over the management of this subsidiary as President of the GMED. A graduate of ENSEEIHT (Toulouse), Lionel Dreux was Director of Scientific and Industrial Metrology at LNE for 10 years.

 

This is a new phase in the history of GMED being written. The GMED can rely on a strong and solid team, which has made it successful for more than 20 years, but also on new employees who will allow it to live up to its ambitions.

Lionel Dreux, President of GMED

 

GMED in figures

• 140 employees, including more than 30 in its subsidiary GMED North America in the USA
• More than 200 employees within 3 years
• A turnover of more than €19 million planned for 2018 (€13.7 million in France and €5.7 million in the USA)
• 850 customers worldwide and more than 3500 active certificates

History of GMED

• 1979 : Creation of GLEM (Groupement des Laboratoires d'Essais des Matériels de technique médicale).
• 1994 : Création of GIE (Groupement d'Intérêt Economique) G-MED (Groupement pour l'évaluation des dispositifs médicaux) with four partners (Ministère en charge de la Santé, Ministère en charge de l'Industrie, LCIE et LNE).
• 1998 : Evolution of the G-MED EIG with two partners (LCIE and LNE)
• 2000 : Creation of the LNE/G-MED antenna in Saint-Etienne
• 2004 : Resumption of the activities of the G-MED GIE of LCIE by the LNE
• 2005 : Dissolution of the GIE -> LNE becomes the only certification body and notified body –> maintenance of the G-MED mark
  Creation of the G-MED North America subsidiary in Washington DC (USA)
• 2018 : Creation of GMED SAS, a wholly-owned subsidiary of LNE

Press contacts

Alexandre Papin • +33 1 40 43 38 92 • alexandre.papin@lne.fr – Valérie Mulot • +33 1 40 43 40 93