Hi All,
What are the regulatory requirements for Rental & Service facilities who purchase medical devices to rent out and install into hospitals and the community. Do they need to ensure that they have evidence that the devices are CE marked and are not subject to a recall or FSN? Are they required to list the devices they rent out with the competent authority? Also, are they obliged to maintain a post market surveillance system, and report any faults back to the manufacturer as they would have to do as a distributor?
Your help will be very much appreciated.
Jo
What are the regulatory requirements for Rental & Service facilities who purchase medical devices to rent out and install into hospitals and the community. Do they need to ensure that they have evidence that the devices are CE marked and are not subject to a recall or FSN? Are they required to list the devices they rent out with the competent authority? Also, are they obliged to maintain a post market surveillance system, and report any faults back to the manufacturer as they would have to do as a distributor?
Your help will be very much appreciated.
Jo