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Class I Medical Device CE Marking

Class I Medical Devices are considered as low risk devices compared to other type of Medical devices. As per European MDD, non-sterile and non-measurable Class I devices are exempted from Notified Body audit and Certification.

Class 1 devices can be divided into three, [a] Class 1 Devices, [b] Class 1 Sterile Devices, [c] Class 1 Measuring Devices:

[a] Class 1 Devices

All Class 1 Medical Devices can affix CE Mark by self-declaration by preparing a Declaration Of Conformity and complying with other requirements. But majority of the manufactures still depend on a third party Certification to get a reputed CE Certificate.

[b] Class I Sterile Devices

Class 1 Sterile Device CE Marking process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified Body and Site Audit.

[c] Class 1 Measuring Devices

Class 1 Measuring Device CE Marking process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified Body and Site Audit. In addition MEDDEV 2. 1/5 guidance to be followed.

Class 1 Medical Device - Examples

  • Arm sling
  • Dental Chair
  • Examination Gown
  • Forceps
  • Mask
  • Patient Bed
  • Reusable surgical instruments

  • Splint
  • Sterilization wrap
  • Stocking
  • Tong depressor
  • Tooth brush
  • Urine bag
  • Wheel chair

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

 
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