All MD or IVDMD must comply with requirements stipulated in European Directives in order to be marketed within the European Union. The involvement of a notified body is essential for the majority of such devices. The LNE/G-MED entity (EC 0459), as a notified body empowered by the ANSM Medication Safety Agency, proposes a set of certification services to address this regulation.
Manufacturers can contract LNE/G-MED for assistance in applying European Directives for a wide array of product categories, as well as for the full set of designated methods of proof:
LNE/G-MED provides information relative to regulations and the procedure to follow, in addition to offering expert advice on your product classification and delivering the certifications required for a CE marking, as executed in accordance with Directive appendices:
The category of medical device is determined by application of Appendix IX of Directive 93/42/EEC or Appendix II of Directive 98/79/EC. A European guide called MEDDEV (2.4/1) and a "Borderline" manual are both available from the European Commission's website.
Begin your application to obtain certification within the scope of the CE marking program by requesting the information questionnaire with a simple click on the "Obtain a quote" button.