Post-Market Surveillance Plan (IVDR)
Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.
Definition
Article 79 and Annex III of the IVDR require every manufacturer to plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class and appropriate for the type of device. The PMS Plan defines the data sources (complaints, PMPF, literature, registries), the indicators and thresholds, and the linkage back into risk management and the performance evaluation.What this means in practice
For Class A and B devices the outputs feed a PMS Report (Article 80); for Class C and D they feed a Periodic Safety Update Report (PSUR, Article 81) that is reviewed by the notified body for Class C and D and, for Class D, made available through EUDAMED.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.
Activities to monitor device safety and performance after market release.
Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Article 79 and Annex IIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.