Section F — PMS, PMCF and the plan for updates
Source: MDCG-2020-01.pdf page 21 (document: MDCG 2020-13)
Section F: PMS, PMCF and the plan for updates
Documents reviewed, where relevant:
- PMS Plan
- PMS Report (where relevant)
- PMCF Plan
- PMCF Report (where relevant)
- PSUR (if available)
Include references to the above documents.
The demonstration of equivalence and the link to post-market clinical follow-up
Describe how the manufacturer will verify the presumption that there would be no clinically significant difference in the safety and clinical performance of the device under evaluation compared with the equivalent device by post market surveillance or post market clinical follow-up?
Is there a post-market clinical follow-up planned?
State Yes / No
Is this an implantable or class III device for which clinical investigations have not been performed in accordance with Article 61(4)?
State Yes / No
For these devices the PMCF plan should include post market clinical studies to demonstrate the safety and performance of the device.
Comments on appropriateness of PMS/PMCF Plan:
_____
If no PMCF is planned, has the manufacturer provided an acceptable justification for not conducting a PMCF?
State Yes / No
Clinical evaluation updates:
Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and which frequency should be considered.
Provide further detail taking into account the manufacturer's PMCF plan and the post-market surveillance plan.
Non-compliances identified and resolved for this section may be briefly described in this box
The PMS, PMCF and the plan for updates are:
- Compliant with the applicable requirements of the MDR:
Include any relevant comments
- Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:
Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.