Fully refurbishing process

[GiuliaGe]

Good morning to you all!

My name is Giulia and I work as a Regulatory Affairs Specialist in a company that produces active medical devices.

We would like to understand more about the fully refurbishing process

Fully refurbishing is defined inthe MDR regulation as "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";

Since our product has an expected duration of 5 years, we would like to understand if this process could be applied to the products sold under Directive 93/42 by performing a software update and an exchange of labels/IFU/declaration of conformity by authorized persons in order to bring then into conformity with MDR Regulation.

Do any of you have experience with this type of process? is it applicable only to disposable devices?

Thank you,

every advice and food for thought are welcome

Giulia

 

[Billy Milly]

I do not work with such devices, so only some general info.
Refurbishing can apply to all devices, but I believe requirements were focused towards active devices (ultrasound, MR, x-ray...).
It can be applied to MDD devices, but you need to bring the whole "package" in conformity (tech file, not only labels ad IFU...). Risk management would also be different from a "new" device, etc.

 

[GiuliaGe]

Yes, we are applying for MDR for the same device, then the tech file including risk management will be updates as well. The two devices will be differ only for software (that is has to be updated on the field), labels, IFU and tech file.

 

[dgrainger]

Takes a look at NB-MED/2.1/Rec 5 - Placing on the market of fully refurbished medical devices

https://www.team-nb.org//wp-content...rket_of_fully_refurbished_medical_devices.pdf