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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.
Presentation of the certification
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:
- 90/385/EEC: Active implantable MD (including regulation 722/2012 regarding MD manufactured from animal tissue),
- 93/42/EEC: MD (including regulation 722/2012 regarding MD manufactured from animal tissue),
- 98/79/EC: MD used for purposes of in vitro diagnostics.
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:
- EC design examinations,
- standard EC assessments,
- EC verifications,
- Quality system audits.
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.
Obtaining certification
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.
