As outlined in Part 1 of this series, since May 26, 2022, the In Vitro Diagnostic Regulation (IVDR) has made Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) mandatory for all IVD devices, including legacy devices in classes A through D. However, many manufacturers are still unaware that their legacy devices, even those yet to transition from IVDD to IVDR, must already comply with these requirements.
Understanding PMPF: A Critical Component of PMS
PMPF is a vital element of PMS under the IVDR. It ensures that the performance evaluation of CE-marked IVD devices remains current throughout their lifecycle. The primary objectives of PMPF are to:
- Confirm the device’s safety, performance, and scientific validity
- Detect emerging risks
- Identify potential systematic misuse
Getting Started with PMPF Implementation
The first step is integrating PMPF into your Quality Management System (QMS). Your procedures should align with Annex XIII Part B of the IVDR and establish clear connections between PMPF and other key processes such as risk management, CAPA, performance evaluation, and the Summary of Safety and Performance (SSP).
Key deliverables include:
- PMS Plan (including or referencing a PMPF Plan)
- PMS Report (Class A and B)
- Periodic Safety Update Report (PSUR – Class C and D)
- PMPF Plan
- PMPF Evaluation Report
If PMPF is not applicable to a device, a justification must be documented in the Performance Evaluation Report (PER). However, if there are residual risks, uncertainties, or potential changes in performance over time (e.g., due to evolving clinical practices or new viral strains), PMPF is required.
Designing Your PMPF Plan
Your PMPF Plan should outline both general and specific methods for collecting and evaluating post-market data. These may include:
- User feedback
- Clinical experience
- Scientific literature reviews
- Ring trials
- Epidemiological studies
- Registry evaluations
- Dedicated PMPF studies
To identify specific methods for your device, review your PER including indications for use, intended population, clinical safety and performance requirements, clinical claims and clinical benefits. Identify any gap(s) in the clinical data and to formulate questions that should be addressed by PMPF. Consider any outstanding residual risks and how to address these by e.g., user surveys or performing additional usability studies.
Structured literature searches must follow systematic methodologies to meet IVDR standards. Also, be vigilant for signs of systematic misuse (e.g., off-label use), which should be distinguished from use errors. Modifications by healthcare institutions may fall under the in-house exemption (IVDR Article 5.5), provided the institution meets the specified conditions.
Reporting and Frequency
All devices require a PMPF Evaluation Report. Summaries of PMPF findings must be included in:
- PMS Reports (Class A and B)
- PSURs (Class C and D)
The frequency of updates should be risk-based. For Class C and D devices, annual updates are strongly recommended, as PMPF findings feed into the PER and PSUR. Notified Bodies will scrutinize adherence to PMPF commitments during surveillance audits, and failure to comply may jeopardize certificate renewal.
Additional updates may be necessary in response to:
- Serious adverse events
- Complaint trends
- Emerging risks
- Newly identified performance issues and limitations
Special Considerations for IVDD Legacy Devices
Legacy devices with valid IVDD certificates or Declarations of Conformity must also meet most PMS and PMPF requirements. According to MDCG 2022-8, premarket documents like the SSP and PER are not required for these devices. However, a PMS Report is still expected, and while a PSUR is not mandatory, manufacturers may choose to prepare one voluntarily. The PMPF Plan must still define the frequency and methodology for updating the PMPF Evaluation Report, based on device risk.
Final Thoughts
PMPF is not a one-time task—it’s a continuous process that ensures your device remains safe, effective, and scientifically valid throughout its lifecycle. While implementing PMPF under the IVDR requires time, resources, and strategic planning, it is essential for maintaining compliance and safeguarding your CE certification.
At Qserve, we specialize in supporting manufacturers managing the complexities of PMS and PMPF under the IVDR. Whether you need support developing robust plans, identifying appropriate PMPF methods, or executing studies, our team is here to guide you every step of the way.
Reach out to us today to explore how we can support your PMPF strategy and ensure your IVD devices remain compliant and competitive.
Read part 1: How to get started with Post Market Surveillance under the IVDR.