Hi !
Let's say :
- I am a manufacturer of configurable devices (medical gas pipeline systems - MGPS) which are installed in healthcare institutions and intended to be used for a long period (over 15y.).
- Over their intended service life, these configurable devices may require maintenance, either in the case of an issue e.g. a component that needs to be replaced, or because the health institution wants to modify the configuration of the device.
- The devices I installed in the past as a manufacturer are covered by an MDD CE certificate. The "ownership" of the installed device is transferred to the health institution after installation. The health institution is free to come to my company for maintenance or go to another certified company.
- My MDD certificate will soon expire and because of the effort required for getting a CE mark under EU MDR, I decide to stop installing MGPS (I will still continue doing business with other non-medical gas systems).
- A third party owning an MDR CE certificate for similar products wants to take over my business.
How does the responsibilities (e.g. PMS, vigilance, records retention, etc.) split between me going out of business and that third party who would like to take over ?
Looking forward hearing from the community !
Let's say :
- I am a manufacturer of configurable devices (medical gas pipeline systems - MGPS) which are installed in healthcare institutions and intended to be used for a long period (over 15y.).
- Over their intended service life, these configurable devices may require maintenance, either in the case of an issue e.g. a component that needs to be replaced, or because the health institution wants to modify the configuration of the device.
- The devices I installed in the past as a manufacturer are covered by an MDD CE certificate. The "ownership" of the installed device is transferred to the health institution after installation. The health institution is free to come to my company for maintenance or go to another certified company.
- My MDD certificate will soon expire and because of the effort required for getting a CE mark under EU MDR, I decide to stop installing MGPS (I will still continue doing business with other non-medical gas systems).
- A third party owning an MDR CE certificate for similar products wants to take over my business.
How does the responsibilities (e.g. PMS, vigilance, records retention, etc.) split between me going out of business and that third party who would like to take over ?
Looking forward hearing from the community !
