Use of Field-Recovered Components in Manufacturing of New Medical Devices (US / EU Perspective)

[UDIspec]

From a US FDA and EU MDR perspective is there any explicit regulatory prohibition on using a field-recovered, non-patient-contacting component (like internal shielding or structural elements) from a retired capital equipment medical device on a new device of the same model by the same manufacturer?

We are planning to have the appropriate testing and inspection upon receipt? Just curious is there any problem if we still call the new machine "new"? It is not even 2% of the machine and it is not crucial either just a piece of metal.

 

[Jean_B]

As far as I know there is no prohibition, but there are obviously risks involved that need to be assessed and if applicable controlled for. Accumulation of stresses/wear & tear, cross-contamination, provenance/traceability, presence of undetectable (ESD) damage.

Of the top of my head also look at the terms refurbished versus remanufactured. I think they were in IEC 62363, which deals with recurrent testing and testing after repair. Don't have access anymore though.

 

[Bev D]

Typical legal rulings indicate that if you sell as refurbished then ok. But I wouldn’t do it.