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Class IIb Medical Device CE Marking

Class IIb Medical Devices are considered as high risk devices compared to Class I and Class IIa type of Medical devices. Class IIb Medical Devices require, Product testing, Quality system implementation (ISO 13485) Techinical file preparation, Notified Body audit and Certification.

Class IIb Medical Device - Examples

  • Blood bag
  • Contact lens solution
  • Condom
  • Dental Implant
  • Intra ocular lens

CE Classification may change depends on the intended use, please check with MDD 93/42/EEC ANNEX IX for your device classification.

LMG can assist you with

  • Medical Device Classification
  • Identification of MDD requirements
  • Identification of Harmonized standards
  • ISO 13485 Implementation
  • Identification of Notified Body
  • Technical File preparation
  • Technical File submission to Notified Body
  • Technical file re-submission
  • Assistance with Notified Body audit
  • Assistance in closing non-conformities
  • Affix CE Mark

 
LIBERTY MANAGEMENT GROUP LTD.
75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@libertymanagement.us