IVDR PMPF, PMS, PSUR & Vigilance

Performance evaluation does not end at CE marking. Post-Market Performance Follow-up (PMPF) is a proactive evidence engine designed to confirm or further characterize specific diagnostic performance questions throughout the commercial lifecycle.

Strengthen Your IVDR Post-Market Evidence

The Closed-Loop Lifecycle Evidence Cycle

PMS / Complaint Data

Performance Signals

Risk Management Update

PMPF Execution

PER Annual Update

Claims / Labeling / CAPA

13 Key IVDR Post-Market Compliance Deliverables

PMS Plan and PMS Report compilation (Class A and Class B IVDs)

PSUR strategy and annual/biennial preparation (Class C and Class D IVDs per Article 81)

PMPF Plan linked directly to residual analytical and clinical uncertainties

PMPF Evaluation Report authoring and integration into the PER

Scientific validity surveillance & state-of-the-art literature monitoring

Analytical performance trend monitoring across commercial reagent lots

Real-world clinical performance monitoring and user feedback analysis

Complaint data evaluation, signal detection and statistical trending

Vigilance, serious incident assessment and Competent Authority reporting under Article 82

Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) support

ISO 14971 risk management file updates based on post-market findings

Summary of Safety & Performance (SSP) annual updates for Class C & D devices

Design and reagent change-control linkage to maintain certified status

Expert Differentiator

Targeted Post-Market Evidence, Not Generic Surveys

PMPF must not be generic customer satisfaction surveys. It should be specifically designed to confirm or further characterize the defined analytical and clinical performance questions that remain after initial CE marking.

PSUR Deadlines (Article 81)

Class D IVDs: Annual PSUR + EUDAMED upload + Notified Body review

Class C IVDs: Annual PSUR update

Class A & B IVDs: PMS Report updated as necessary

Draft Your IVDR PSUR

Ensure timely submission of compliant IVDR PSUR and PMPF evaluation reports.

Request PMPF Support

Maintain Defensible Real-World Evidence for Your IVD Portfolio

Our post-market scientists establish proactive PMPF and PMS frameworks that preserve CE mark certification.

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