Medical Devices Regulations

10 A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to

• (a) identify the risks inherent in the device;

• (b) if the risks can be eliminated, eliminate them;

• (c) if the risks cannot be eliminated,

  • (i) reduce the risks to the extent possible,

  • (ii) provide for protection appropriate to those risks, including the provision of alarms, and

  • (iii) provide, with the device, information relative to the risks that remain; and

• (d) minimize the hazard from potential failures during the projected useful life of the device.