Medical Device Classification Class IIa

Class IIa Medical Device

Class IIa devices 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.

MDR Class IIa 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 Regulation-MDR.

We support class IIa Medical Device manufactures with the following Services

(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.

More details about CE Certification Process click here .

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