Medical Device Classification Class IIa

Class IIa Medical Device

Class IIa Medical 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.

Possible Class IIa CE Certification options

  • 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

MDR 2017/745 PDF File Download >>

CE Marking Request For Quote >>

We offer class IIa Medical Device clients

(a) Guidance & Technical File

(b) Identify test requirments and review the external reports.

(c) Arrange Notified Body and Coordinate with them till issue of CE Certificate.

(d) Arrange EU Representative from Europe

(e) Arrange Free Sale Certificate from Europe.

Know more about CE Marking Process >>

Know more about MDR Technical Documentation >>

Know more about MDR Clinical Documentation >>

More details about CE Certification Process click here .

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