Class 11b Medical Device

As per MDD classification and related directive Class 11b device are critical. Design review and QMS implementation will be verified along with technical file and Clinical investigation documents. Conformity assessment by a Notified Body is required before affixing CE Mark.

Class 11b CE Certification - follow any of the below mentods:

  • Type / Batch Examination and testing as per Annex IV
  • Onsite Audit of the production quality assurance system (Annex V) including Design
  • Audit of final inspection and testing (Annex VI) excluding Design & Manufacture
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2012

MDD Annex can be obtained from Medical device directive.

More about process of certification click here .

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