{{RegDocument
| area_of_validity  = EU
| scope             = IVD
| document_type     = Regulation – Article Reference
| name              = IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up
| version           = 2017/746
| source            = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e6179-1-1
| language          = EN, DE, FR
| status            = Current
| restricted_access = No
}}

Articles 78 to 81 and Annex XIII Part B of the IVDR establish the mandatory post-market performance follow-up (PMPF) system for IVD manufacturers. PMPF is the IVD equivalent of PMCF under the MDR.

== Summary ==

Manufacturers must proactively collect and evaluate data from devices already on the market to confirm safety, performance, and scientific validity throughout the device lifetime.

Key obligations:

* Article 78 – General post-market surveillance requirements
* Article 79 – Post-market surveillance plan
* Article 80 – Post-market surveillance report (Class A and B devices)
* Article 81 – Periodic Safety Update Report (PSUR, Class C and D devices)
* Annex XIII Part B – PMPF plan and PMPF evaluation report requirements

== Related documents ==

* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parent document
* [[MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF]] – Equivalent provision for medical devices

[[Category:In Vitro Diagnostics]]
[[Category:Post-Market Surveillance]]
[[Category:Clinical]]
