Medical Device Class IIb /2b

Class 2b 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.

Possible Class 2b Medical Device CE Certification options

  • 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

MDR 2017/745 PDF File Download >>

CE Marking Request For Quote >>

We support class IIb Device manufactures 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) Periodic Safety Update Report.

(h) Arrange Free Sale Certificate from Europe.

Know more about CE Marking Process >>

Know more about MDR Technical Documentation >>

Know more about MDR Clinical Documentation >>

Client Testimonials.

Surgick LLC; Reviewed by Mr. John on . Great Team!. Thanks for provide a great support and Guidance on Class 2b Medical Device. Rating: 4.9

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