LNE/G-MED is the sole French notified body for the European Directives covering medical devices.
It is notified by the French authorities (identification no. 0459) to the European Union member states and the European Commission for the following Directives:
Its notification covers:
For the medical device Directives 90/385/EEC, 93/42/EC, 98/79/EC, 2000/70/EC and 2003/32/EC, LNE/G-MED will:
The class of a medical device depends on its intended use as specified by the manufacturer.
To determine which class your device belongs to, consult the revised text of Annex IX* (49 kB) of Directive 93/42/EEC, which sets out the applicable classification rules.
The classification guide MEDDEV 2.4/1 Rev.8 explains the general rules set out in Annex IX of the Directive. It can be downloaded from the European Commission website.
For in vitro diagnostic devices, consult Annex II (154kB) of Directive 98/79/EC.
For breast implants, consult Directive 2003/12/EC (94kB)
For joint replacements, consult Directive 2005/50/EC (46kB)
For more information on procedures for access to CE marking, LNE/G-MED published a guidelines for all manufacturers who need to apply CE marking to their products. They contain full information on:
The guide is being updated. Leave us your details if you want to be informed of its publication.
For information on the LNE/G-MED certification process, see the section Obtaining certification