Regulatory Open Forum

Under MDR Article 120 you must implement the EU-MDR PMS system which includes plans, reports, clinical evaluation updates, risk management updates, etc. The details are specific to the EU-MDR; no other regulatory region requires this system.

I believe it is the most comprehensive and complicated system. As a result, it will become the de facto system. While you don't need to implement it for all regulatory regions, there is a cost to having multiple systems.

Under MDR Article 120 you must implement the EU-MDR PMS system which includes plans, reports, clinical evaluation updates, risk management updates, etc. The details are specific to the EU-MDR; no other regulatory region requires this system.

I believe it is the most comprehensive and complicated system. As a result, it will become the de facto system. While you don't need to implement it for all regulatory regions, there is a cost to having multiple systems.

I'll give you a definite maybe.

I have a client who sells devices to large diagnostic imaging manufacturers. All my client's sales are in the US, but the customer could send the device to many regulatory regions. In this case, the PSUR is global sales using US sales as a surrogate.

I have another client who can identify the EU sales, so their PSUR is EU only.

There is another wrinkle in the fabric of the MDR's space/time continuum.

If you have a serious incident, you will complete an MIR which requires global sales trend analysis based on IMDRF codes. While this vigilance element is not part of PMS, it has some similarities in terms of data collection and analysis.

Your PMS system database and your Vigilance System database needs to support PMS reports, MIRs, and Art. 88 reports.

Under MDR Article 120 you must implement the EU-MDR PMS system which includes plans, reports, clinical evaluation updates, risk management updates, etc. The details are specific to the EU-MDR; no other regulatory region requires this system.

I believe it is the most comprehensive and complicated system. As a result, it will become the de facto system. While you don't need to implement it for all regulatory regions, there is a cost to having multiple systems.

I'll give you a definite maybe.

I have a client who sells devices to large diagnostic imaging manufacturers. All my client's sales are in the US, but the customer could send the device to many regulatory regions. In this case, the PSUR is global sales using US sales as a surrogate.

I have another client who can identify the EU sales, so their PSUR is EU only.

There is another wrinkle in the fabric of the MDR's space/time continuum.

If you have a serious incident, you will complete an MIR which requires global sales trend analysis based on IMDRF codes. While this vigilance element is not part of PMS, it has some similarities in terms of data collection and analysis.

Your PMS system database and your Vigilance System database needs to support PMS reports, MIRs, and Art. 88 reports.

Under MDR Article 120 you must implement the EU-MDR PMS system which includes plans, reports, clinical evaluation updates, risk management updates, etc. The details are specific to the EU-MDR; no other regulatory region requires this system.

I believe it is the most comprehensive and complicated system. As a result, it will become the de facto system. While you don't need to implement it for all regulatory regions, there is a cost to having multiple systems.