In vitro diagnostic medical devices
Directive 98/79/EC

Status of LNE/G-MED: notified body
Accreditation number: 0459
Services provided by LNE:
LNE will:
provide expert advice concerning classification of devices and certification procedures
examine product design,
carry out EC type-examinations,
approve and monitor your production quality system in accordance with Directive Annexes,
test manufactured products for reagents specified in Annex II list A (batch release procedure).

Scope:
All in vitro diagnostic medical devices and their accessories.

How to comply with the Directive?
Download the LNE/G-MED Guidelines (PDF format)

LNE/G-MED strengths:
LNE/G-MED applies the most appropriate formula for batch tests (complete or partial tests).
Regulatory precedence is systematically recognized, and reagents already registered in France will not need to be reassessed.
Certificates are issued for all completed conformity procedures.
Technical file examinations and audits are performed by qualified experts who are specially trained for each category of devices. They work in close cooperation with a team of internationally recognized biologists.

Additional services:
one-stop auditing for ISO 9001, EN/ISO 13485 and EN/ISO 13488 certification
training (in French)
one-day technical information sessions (in French)

Recognition by third-party bodies:
LNE/G-MED is approved by the following accreditation bodies:
- COFRAC (France) for all voluntary company certification
- SCC (Canada) for ISO 13485 and 13488 certification (CMDCAS programme)
- FDA (United States) for file examination according to 510k procedure.

Contact: Customer service