Sterilisation of Medical Devices

Hi all,

I remember reading somewhere that if I Sterilize a non-sterile Medical Device it makes me the legal manufacturer of that Device but I can not find it now.

The only thing I have found is MDR 2017/745 Article 2 -
(30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

(31) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;

This does not specifically mention Sterilization of Devices. Am I misinterpreting or missing something?

For clarity, this question is being raised by myself. I had a quote for a Swiss AR declined because legal ownership of devices in a Procedure Pack has not been determined by Swissmedic.

 

Are you marketing the device under your (company) name? Are you responsible for managing complaints, recalls, etc.? I think those questions are more relevant than whether you sterilize. Many companies outsource sterilization of their device and that doesn't make the (contract) sterilizer the legal manufacturer.