PMCF Case Study : End-to-end EU-MDR support for a Class III legacy medical device (PICC catheter) using PMCF survey solution with 500+ survey data collected across the USCAN and Europe in 8 weeks!
Client challenge / Objective
The client wanted to capture PMCF data for their legacy PICC device which has been in the market for many years but has limited clinical data for EU MDR 745/2017 compliance
They wanted to collect PMCF data for EU MDR 745/2017 compliance in a quick, cost-effective, and high-quality manner.
It was mandatory to have Rank 4 Clinical Evidence for this submission
Scope
Streamlining the PMCF plan with PMCF survey protocol
Sample Size: 575 retrospective patient case forms
Timeline: 8 weeks
Regions: USCAN and Europe
Outcome
By adhering to relevant regulatory requirements and guidelines, in alignment with ISO 14155 principles and GDPR compliance, throughout the PMCF process, and following a robust PMCF survey methodology we were able to attain a Level 4 ranking in Clinical Data.
Significant cost and timeline reduction Vs. other means of PMCF data collection methodology (specific methods)
Cetas Healthcare Solution Overview
CER Gap Analysis:
Review CER to check any potential gaps in clinical data
Identification of clinical endpoint (Primary & secondary)
Literature review in case of inadequacy found in clinical endpoint for the subject device
Review of SOTA for better understanding and analysis of stand of care and benchmark device
Review/Map reference data source for clinical data
Mapping of indication/claim against clinical data
Mapping of adverse events as per IFU
Drafting PMCF Survey plan for the product family :
Define clinical outcome along with sample size and its criteria in the PMCF survey plan.
Draft the PMCF survey questions to be included in the online survey.
Execution of PMCF survey clinical data collection :
Design a questionnaire document with survey best practices.
Program the survey online and hold a final discussion with the client before launching a pilot survey.
Launch the survey among relevant target respondents and capture data in an EDC platform.
Collect comprehensive raw clinical data including product indication, outcomes, adverse events, and off-label use.
Drafting and finalizing the PMCF Survey report :
In-depth analysis of clinical data with respective graphs and conclusions.
Accurate mapping of indication and clinical outcomes against the individual products with a graphical representation and capturing of AE’s and off-label usage.
Upon completion, submit draft of PMCF report to client clinical team for review.
CER Remediation/Update :
Prepared updated CER for submission
Ensured compliance with regulations
Provided supporting documentation as needed
PMSR/PSUR Update :
Prepared updated PMSR/PSUR for submission
Ensured compliance with regulations
Provided supporting documentation as needed
NB Liaison :
Supported with the interim report for PMCF for NB.
Assisted in drafting responses to NB’s technical, clinical, and biological inquiries.
CER Gap Analysis Approach Overview
Gaps
Although the client had an existing CER, there were some gaps in it the CER that was identified such as:
1Gaps in subject device's clinical endpoint and acceptance criteria
2The SOTA section was relatively brief
3Insufficient clinical data in the CER for specific indications
4The performance endpoint was inadequate to measure the device’s intended purpose
5Lack of literature to support the dwell time and completion of treatment parameters in the CER
Solutions
Using Our tailored PMCF survey the below methods helped to fill gaps and enhance CER’s reliability.
Through our survey, we gathered additional data to address gaps in clinical endpoints and acceptance criteria1
Included a survey section to incorporate the latest and most relevant information about the product2
Included questions to gather insights on additional parameters for better evaluation of specific indications3
Included questions on the effectiveness of performance endpoints4
Included questions on real-world dwell time and success rate of implantation5
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