Additionally, can someone send a strict definition for repair and refurbishment?
Eyal
Eyal,
The whole regulation for repair and refurbishment is still a work in progress.
Below is a set of purposed definitions taken from US Federal Register Number: 2016-04700.
1. Recondition: Restores and/or refurbishes a medical device to the OEM's original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.
2. Service: Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
3. Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
4. Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.
5. Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use.
6. Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.