35 lines
1.5 KiB
Plaintext
35 lines
1.5 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = MD
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| document_type = Regulation – Article Reference
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| name = MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF
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| version = 2017/745
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e6354-1-1
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| language = EN, DE, FR
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| status = Current
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| restricted_access = No
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}}
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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).
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== Summary ==
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Manufacturers must plan, establish, document, implement, maintain, and update a PMS system proportionate to the risk class of the device.
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Key obligations:
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* Article 83 – General PMS requirements and system structure
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* Article 84 – PMS plan (content requirements)
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* Article 85 – PMS report (required for Class I devices)
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* Article 86 – Periodic Safety Update Report (PSUR, required for Class IIa, IIb, III)
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* Annex XIV Part B – PMCF plan and PMCF evaluation report requirements
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== Related documents ==
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* [[Medical Device Regulation (EU) 2017/745]] – Parent document
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* [[IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up]] – Equivalent provision for IVDs
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[[Category:Medical Devices]]
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[[Category:Post-Market Surveillance]]
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[[Category:Clinical]]
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