Class 111 Medical Device

Most critical medical devices based on MDD are categorized under Class 111. All Class III device manufactures has to undergo stringent performance and safety tests compared to others. Class III device manufactures has submit the Design Dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option.

Notified Body must carry out audit under Annex II full quality assurance system (EN ISO 13485:2012), plus that the manufacturer must submit the Technical File / Design Dossier to the Notified Body for approval under Annex II,
(OR)
Type-examination (Annex III) plus one of the two options given here:

  • Batch Inspection as per Annex IV
  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2012 (with mandatory Design evaluation)

Visit EU Website for more details about Medical device directive.

All about class 111 certification process click here .

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