Clinical Evaluation Plan vs. PMCF Plan

[Weeder]

Generally speaking - it's hard to make sense of EU regulation, not to mention effectiveness
Clinical evaluation plan is essentially search & review exercise plan. It is a must under MDD/MDR.
Post-Market Clinical Follow up is essentially a post-market clinical investigation plan. It is not a must under MDD/MDR. You do it when clinical evaluation is not sufficient to confirm the safety and performance of the device.

In my Post-Market Surveillance System SOP - I refer to both processes.
In the PMS plan - I refer to both processes.
The execution - clinical evaluation and investigation are done separately.

Cheers,
Shimon

The MDR requires that the post-marketing surveillance data be used to update the clinical evaluation, risk management and if required manufacturing and production processes. How do you indicate this in your procedural documents?

For example, when there is PMS data that requires that the risk profile be updated or the clinical evaluation be updated, how do you know what to do next? what is the mechanism that tells you that you have to update the clinical evaluation? or risk management? I need to add this to my procedures.

 

[DamienL]

I'll give this a stab.
I think the various plans (PMS/CEP/RMP) are the mechanism to trigger updates. So there would be one of two ways to make sure stuff gets done:
1) the plan* says that the owner of the plan needs to proactively acquire the information that their plan needs (e.g. the PMS data).
2) the plan* says that the owner of the information feeding into the plan (e.g. the PMS data) needs to proactively provide it to the plan owner. In this case, your PMS procedure would say that the PMS process owner is responsible for disseminating the information to the various plan owner(s).

I've no idea how practical these suggestions are. Probably quite tricky to make sure these plans do actually function as triggers and don't just get forgotten. That's why I'd probably lean towards number 2, particularly for a smaller company.

*Also, as an aside, I don't think the detail of "what to do" needs to be contained in the plan, I would reference as much as possible out to a governing procedure. But I do think each product should have it's own specific plans.

 

[kaitybarry]

The MDR requires that the post-marketing surveillance data be used to update the clinical evaluation, risk management and if required manufacturing and production processes. How do you indicate this in your procedural documents?

For example, when there is PMS data that requires that the risk profile be updated or the clinical evaluation be updated, how do you know what to do next? what is the mechanism that tells you that you have to update the clinical evaluation? or risk management? I need to add this to my procedures.

I think you should consider using trending as your trigger for updating the various QMS processes like clinical evaluation and risk management.

Ask yourself these questions:

1. Have there been an increased amount of serious incidents received?
2. Is there evidence to suggest that the probability or severity of your risks outlined in your risk management system has increased?
3. Are there any clinically significant events (adverse events, deaths, etc.) that aren't addressed in your risk management or clinical evaluation?
4. How many CAPAs have been opened in the course of PMS?
5. Has there been an increase in a specific failure mode where root cause is attributed to the manufacturing process?
6. Has there been any FSCA/FCO/recalls initiated as a result of a complaint or field issue?

A lot of this information will need to be compiled for various QMS activities, like management review or generation of the PSUR/PMSR (depending on device class). In fact, ISO 20416 states that the post market plan be reviewed in management review for updates. So that is one vehicle you can use.

Regardless, setting trigger points (trending limits) is probably the best way to initiate updates. Reaching these limits should automatically require your company to perform a formal risk assessment. That assessment should indicate what needs to be updated.

 

[Weeder]

I think you should consider using trending as your trigger for updating the various QMS processes like clinical evaluation and risk management.

Ask yourself these questions:

1. Have there been an increased amount of serious incidents received?
2. Is there evidence to suggest that the probability or severity of your risks outlined in your risk management system has increased?
3. Are there any clinically significant events (adverse events, deaths, etc.) that aren't addressed in your risk management or clinical evaluation?
4. How many CAPAs have been opened in the course of PMS?
5. Has there been an increase in a specific failure mode where root cause is attributed to the manufacturing process?
6. Has there been any FSCA/FCO/recalls initiated as a result of a complaint or field issue?

A lot of this information will need to be compiled for various QMS activities, like management review or generation of the PSUR/PMSR (depending on device class). In fact, ISO 20416 states that the post market plan be reviewed in management review for updates. So that is one vehicle you can use.

Regardless, setting trigger points (trending limits) is probably the best way to initiate updates. Reaching these limits should automatically require your company to perform a formal risk assessment. That assessment should indicate what needs to be updated.

Thanks, that is an excellent idea.