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Latest update : 10.07.2008
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CE marking

Notification

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:

  • Directive 90/385/EEC covering active implantable medical devices modified by the directive 2007/47/CE
  • Directive 93/42/EEC covering medical devices modified by the directive 2007/47/CE
  • Directive 98/79/EC covering in vitro diagnostic medical devices
  • Directive 2000/70/EC covering medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2003/32/EC covering medical devices utilizing tissues of animal origin

Its notification covers:

  • all categories of medical devices
  • all conformity assessment procedures:
    - type approval
    - approval of quality management systems
    - EC verification

Services

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:

  • provide information on regulations and certification procedures
  • provide an expert opinion concerning classification of devices,
  • issue the certificates required for CE marking,
  • carry out EC examinations of design files,
  • carry out EC type examinations,
  • carry out EC verifications,
  • perform conformity tests to harmonized European standards or other standards,
  • perform quality system audits in accordance with the annexes of the Directives,
  • assess clinical, biological or scientific data, in consultation with hospital experts when required,

Classification of medical devices

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 Format PDF 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 Format PDF Annex II (154kB) of Directive 98/79/EC.

For breast implants, consult Format PDF Directive 2003/12/EC (94kB)

For joint replacements, consult Format PDF Directive 2005/50/EC (46kB)

 

Procedures for access to CE marking

Directives 90/385/EEC and 93/42/EEC (medical devices and active implantable medical devices)

Format PDF Download the procedure (11kB)

Directive 98/79/EC (in vitro diagnostic devices)

Format PDF Download the procedure (64kB)


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:

  • how the Directives must be applied,
  • the links between the Directives and the key European standards,
  • how LNE/G-MED performs each of its tasks,
  • relevant reference documents.

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

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