Repaired/Refurbished medical devices guidelines in Europe?

[Danielkim]

Hello,

Is there any guideline or standard for safety/function inspection of repaired/refurbished medical devices in Europe?
I'm trying to create work flow chart and documentation for our warranty servicing to get ISO 13485 certified in the end.

I'm working for a medical device(class I) company as Importer in Europe, and we do provide warranty service. (our Manufacturer is in US, but they don't have specific warranty service inspection standard)
We provide warranty(repair) service and sell refurbished devices. I would like to review any requirements or guideline to build this inspection criteria or standard for refurbished devices.

It would be the best if we follow our Manufacturer's OQC standard, but we have much smaller space, so it seems impossible to follow everything as they have.

Any tips or guideline I must review before I start this journey?


Your feedback or experiences would be very appreciated.
Best regards,

 

[Orca1]

The MDR does not differentiate between new and refurbished devices, meaning that all devices must meet the same regulatory requirements, and requires that all medical devices must be safe and perform as intended, this includes devices that have been repaired or refurbished. It requires that medical devices:

1. Are designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients.
2. Achieve the performance intended by the manufacturer and are safe to use.
3. Do not pose a risk to the health and safety of persons or, where applicable, domestic animals, when properly installed, maintained, and used in accordance with their intended purpose.

For refurbished devices, it's important to ensure that the device still meets the original manufacturer's specifications and any applicable standards after refurbishment. This may involve functional testing, safety testing, and cosmetic inspection.

Here are some key points to consider when developing inspection criteria or standards for refurbished devices:

1. Safety: The device should be safe to use. This can be demonstrated by compliance with recognized safety standards.
2. Performance: The device should perform as intended. This can be demonstrated by functional testing.
3. Documentation: There should be clear documentation of the refurbishment process, including what was done, why, and by whom. This is important for traceability and accountability.
4. Quality Management: The refurbishment process should be part of the manufacturer's quality management system, which ensures that the process is controlled and consistent.
5. Regulatory Compliance: The refurbished device should still comply with all relevant regulatory requirements.

 

[Danielkim]

The MDR does not differentiate between new and refurbished devices, meaning that all devices must meet the same regulatory requirements, and requires that all medical devices must be safe and perform as intended, this includes devices that have been repaired or refurbished. It requires that medical devices:

1. Are designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients.
2. Achieve the performance intended by the manufacturer and are safe to use.
3. Do not pose a risk to the health and safety of persons or, where applicable, domestic animals, when properly installed, maintained, and used in accordance with their intended purpose.

For refurbished devices, it's important to ensure that the device still meets the original manufacturer's specifications and any applicable standards after refurbishment. This may involve functional testing, safety testing, and cosmetic inspection.

Here are some key points to consider when developing inspection criteria or standards for refurbished devices:

1. Safety: The device should be safe to use. This can be demonstrated by compliance with recognized safety standards.
2. Performance: The device should perform as intended. This can be demonstrated by functional testing.
3. Documentation: There should be clear documentation of the refurbishment process, including what was done, why, and by whom. This is important for traceability and accountability.
4. Quality Management: The refurbishment process should be part of the manufacturer's quality management system, which ensures that the process is controlled and consistent.
5. Regulatory Compliance: The refurbished device should still comply with all relevant regulatory requirements.

Thank you very much for your reply.

Is it still okay to ensure safety and performance as it's intended even if we can't have same testing devices as manufacturer?

 

[Orca1]

Is it still okay to ensure safety and performance as it's intended even if we can't have same testing devices as manufacturer?

Generally yes. The important thing is to ensure that the chosen testing methodology is appropriate and can adequately demonstrate the safety and performance of the device, and that the testing itself be adequately documented.

 

[Ed Panek]

Be careful of VAT. You must work with your in country agent to understand the value of the repair is not the value of the product for service.,

 

[Danielkim]

Generally yes. The important thing is to ensure that the chosen testing methodology is appropriate and can adequately demonstrate the safety and performance of the device, and that the testing itself be adequately documented.

Thanks ! Shall callibration of testing device be done to demonstrate the testing methodology if needed?

 

[Danielkim]

Be careful of VAT. You must work with your in country agent to understand the value of the repair is not the value of the product for service.,

Sorry, what do you mean by this?