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 = IVD
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| document_type = Regulation – Article Reference
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| name = IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up
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| version = 2017/746
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e6179-1-1
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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 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.
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== Summary ==
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Manufacturers must proactively collect and evaluate data from devices already on the market to confirm safety, performance, and scientific validity throughout the device lifetime.
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Key obligations:
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* Article 78 – General post-market surveillance requirements
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* Article 79 – Post-market surveillance plan
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* Article 80 – Post-market surveillance report (Class A and B devices)
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* Article 81 – Periodic Safety Update Report (PSUR, Class C and D devices)
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* Annex XIII Part B – PMPF plan and PMPF evaluation report requirements
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== Related documents ==
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* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parent document
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* [[MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF]] – Equivalent provision for medical devices
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[[Category:In Vitro Diagnostics]]
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[[Category:Post-Market Surveillance]]
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[[Category:Clinical]]
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