Class IIa medical devices (conformity assessment)

ProductClass_i_iia

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For Class IIa medical devices, like hearing aids or dental fillings, one of the following procedures has to be implemented in addition to the conformity assessment procedure according to Annex VII,:

  • Procedure according to EC – type examination according to Annex IV
  • Conformity assessment procedure according to Annex V (production QA)
  • Conformity assessment procedure according to Annex VI (product QA)
  • Conformity assessment procedure according to Annex II