ISO TC 210 is proposing a new standard - ISO 20417 - Medical Devices — Information to be provided by the manufacturer.
The objective of the standard is to set general requirements for information that the manufacturers have to provide to the user for a safe device use.
Right now, several product standards have requirements for information, and there's a lot of duplication. Having one standard that details general information requirements for all devices will enable product standards to call this standard, and then only have additional requirements for that particular device.
The objective of the standard is to set general requirements for information that the manufacturers have to provide to the user for a safe device use.
Right now, several product standards have requirements for information, and there's a lot of duplication. Having one standard that details general information requirements for all devices will enable product standards to call this standard, and then only have additional requirements for that particular device.