Class 11a Medical Device

Class 11 a device are critical compared to class 1 devices. Self declaration is legally not possible. Technical File should be submitted to the Notified Body and conformity assessment by Notified Body is required before affixing CE Mark.

MDD Class 11a CE Marking can be achieved in the following methods:

  • Examination and testing of each product or homogenous batch of products (Annex IV)
  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2012 (excluding Design)
  • Audit of final inspection and testing (Annex VI) EN ISO 13485:2012 (excluding Design & Manufacture)
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2012

Details about Annex can be obtained from Medical device directive.

More details about process of certification click here .

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