Rental, service & installation - regulatory requirements

JoCam

Trusted Information Resource
#1
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
 
Elsmar Forum Sponsor

RA_QA_Expert

Involved In Discussions
#2
Hi Jo,

although they rent the medical devices, they are still distributor (they make product available on the EU market).

MDD has no specific requirements on the distributor, but any distributor should act in accordance with "EC Blue Guide", chapter 3.

As soon as MDR is in force (since May 26, 2021), any distributor shall meet MDR requirement (article 14).

EC Blue Guide and MDR have very similar requirements.

Regarding the service (repairs and preventive maintenance), general information you can find also in EC Blue Guide, but this topic is managed by local laws of Member States.


Q&A
Do they need to ensure that they have evidence that the devices are CE marked?
A: YES, they do

Are they required to list the devices they rent out with the competent authority?
A: It depends on local law in the member state where the product is rent.

Also, are they obliged to maintain a post market surveillance system, and report any faults back to the manufacturer?
A: YES, they are
 

JoCam

Trusted Information Resource
#3
MDD has no specific requirements on the distributor, but any distributor should act in accordance with "EC Blue Guide", chapter 3.

As soon as MDR is in force (since May 26, 2021), any distributor shall meet MDR requirement (article 14).

EC Blue Guide and MDR have very similar requirements.
Thank you very much RA_QA_Expert.
 
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