Medical Device Class IIb /2b

Class IIb Medical Device

As per Medical Device Regulation (MDR) Class IIb Medical Device are critical. Design review and QMS implementation will be verified along with the technical file and Clinical Evaluation (meddev Rev 4) documents. Conformity assessment by a Notified Body is required before affixing CE Mark.

Class IIb CE Certification can be achieved by following any of the below menthods:

  • 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 13485:2016

Details about Annex can be obtained from Medical Device Regulation-MDR.

We support class IIb Medical Device manufactures with the following Services

(a) Guidance & Technical File

(b) Identify Biocompatablity test requirments and review the external Protocols and Reports.

(c) Prepare Clinicial Evaluation Reports as per Meddev 2.7/1 Rev 4.

(d) Conduct Risk Analysis and prepare Risk Management File as per EN ISO 14971.

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

(f) Arrange EU Representative from Europe

(g) Arrange Free Sale Certificate from Europe.

More details about CE Certification Process click here .

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