European Regulations defining the terms Repair and Refurbish

E

eyalhend

Starting to get Involved
#1
#1
Hello all,
I'm part of a company designing and manufacturing class II active devices.
I'm trying to figure whether the European regulations define the terms Repair and Refurbish, and provide requirements/guidelines on these two processes.
I assume that it is not suppose to be limited to labeling and ATPs.

Thanks!
 
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P

Pads38

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#2
#2
Under the current directives (MDD 93/42) I do not think there is any reference to either repair or refurbishment.

Under the forthcoming Regulations (MDR) I think there are controls put in place to cover "re-manufacture". This demands that an operator that undertakes re-manufacture takes on the legal requirements of the device manufacturer.

(IIRC there are definitions as to what is repair versus re-manufacture).
 
shimonv

shimonv

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#4
#4
I'm of the same option as Pads38 that the european community has not issued specific regulations regarding the use of repaired or refurbished medical device.

Cheers,
Shimon
 
E

eyalhend

Starting to get Involved
#5
#5
Thanks all,
Regarding refurbishment, I could only locate reference in the guidance document from the European Coordination of Notified Bodies ‘Placing on the market of fully refurbished medical devices’ NB-MED/2.1/Rec5.
But the above refers to ‘Fully refurbished’ which is considered to mean that a
device has been completely rebuilt / made as new from used devices and is assigned a new ‘useful life’.
No reference to "partial" refurbishment. Thus, do you recommend not to including a protocol for such process but to include it under service activities?

Additionally, can someone send a strict definition for repair and refurbishment?

Thanks a lot!
Eyal
 
shimonv

shimonv

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#6
#6
eyalhend said:
Additionally, can someone send a strict definition for repair and refurbishment?

Eyal
Click to expand...
Eyal,
The whole regulation for repair and refurbishment is still a work in progress.
Below is a set of purposed definitions taken from US Federal Register Number: 2016-04700.

1. Recondition: Restores and/or refurbishes a medical device to the OEM's original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.

2. Service: Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).

3. Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.

4. Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

5. Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use.

6. Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.
 
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