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Aerosure is classified as a Class I respiratory device

General medical devices (that fall within the scope of the Medical Devices Directive) are categorised into classes according to the degree of risk inherent in the device.

General medical devices are grouped into four classes as follows:

  • Class I - generally regarded as lowest risk
  • Class II - generally regarded as medium risk
  • Class III - generally regarded as medium/high risk
  • Class IV - generally regarded as the greatest risk

Conformity assessment requires the manufacturer of a Class I medical device to demonstrate that:

  • Claims made in relation to the device’s safety and performance – under its normal conditions of use – are achieved
  • The clinical benefits associated with the use of the devices outweigh the clinical risks; usually with clinical data

Legislation allows that evidence of the satisfactory clinical safety and performance of a medical device may be provided:

  • In the form of a critical evaluation of published and/or unpublished data on this device, or
  • On one or more similar devices for which equivalence can be demonstrated

In Canada, AeroSure is classified in accordance with SOR/98-282 Medical Device Regulations Schedule 1 - Applied Rules 2(2) and 12 as a Class I respiratory device. Aerosure is classified in accordance with Annex IX, Rule 12 of the Directive 93/42/EEC, as amended by Directive 2007/47/EC and Clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002, as a Class I respiratory device in Europe and Australia respectively.: