{{RegDocument
| area_of_validity  = EU
| scope             = MD
| document_type     = Regulation – Article Reference
| name              = MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF
| version           = 2017/745
| source            = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e6354-1-1
| language          = EN, DE, FR
| status            = Current
| restricted_access = No
}}

Articles 83 to 86 of the MDR establish the mandatory post-market surveillance (PMS) system for all medical device manufacturers. Annex XIV Part B specifies the requirements for post-market clinical follow-up (PMCF).

== Summary ==

Manufacturers must plan, establish, document, implement, maintain, and update a PMS system proportionate to the risk class of the device.

Key obligations:

* Article 83 – General PMS requirements and system structure
* Article 84 – PMS plan (content requirements)
* Article 85 – PMS report (required for Class I devices)
* Article 86 – Periodic Safety Update Report (PSUR, required for Class IIa, IIb, III)
* Annex XIV Part B – PMCF plan and PMCF evaluation report requirements

== Related documents ==

* [[Medical Device Regulation (EU) 2017/745]] – Parent document
* [[IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up]] – Equivalent provision for IVDs

[[Category:Medical Devices]]
[[Category:Post-Market Surveillance]]
[[Category:Clinical]]