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Class IIa Medical Device CE Marking

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

Class IIa Medical Device - Examples

  • Artificial teeth
  • Dentures
  • ECG Machine
  • Massager

  • Patient Monitor
  • Soft Contact Lense
  • Surgical Glove
  • X-ray film

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