US based company no longer selling in the EU: Clinical Evaluation Report and PMS requirements

[jpes175]

I work for a medical device manufacturer in the US. We had one product line (Class IIb devices) we CE marked for sale in the EU. We have decided not to renew our certificate for MDD/MDR. However, we are still under MDSAP and ISO 13485:2016, and still sell these devices and other Class IIb devices to the US, Canada (Class III) and Australia. Our quality system documentation is very EU/MDD centric, so we have been removing elements that are no longer required.

Specific to the Clinical Evaluation Report and PMS requirements per the EU/MDD/MDR, are there any requirements that would still apply to MDSAP, ISO 13485:2016, and/or specific to the US, Canadian, and Australian markets?

Thank you

 

[Billy Milly]

You should support your devices at least for their lifetime, this includes PMS, vigilance, complaints. In other words, you are off the hook once the lifetime of devices has expired - they are no longer on the market or in use. So MDR is applicable until then.