imdrf clinical evaluation guidance - SERP Analysis

https://www.imdrf.org/documents/clinical-evaluation

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf

https://www.imdrf.org/working-groups/medical-device-clinical-evaluation

https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf

https://www.celegence.com/imdrf-summary-changes-clinical-evaluation-guidance/

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/software-medical-device-samd-clinical-evaluation

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n57.pdf

https://www.imdrf.org/sites/default/files/2021-09/imdrf-cons-clinical-evaluation-mdce-190405.pdf

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-210325-wng65.pdf

https://www.domosalute.com.br/news/anvisa-publishes-imdrf-guides-for-medical-devices-clinical-evaluation/

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n55.pdf

https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en_0.pdf

https://www.fda.gov/media/100714/download

https://www.raps.org/news-and-articles/news-articles/2019/11/imdrf-offers-three-final-clinical-guidelines

https://www.qservegroup.com/eu/en/i957/updated-imdrf-guidance-on-pmcf-studies

https://www.imdrf.org/sites/default/files/2021-09/imdrf-cons-clinical-evaluation-investigation.docx

https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf

https://www.obelis.net/news/new-guidelines-on-clinical-evidence-clinical-investigation-and-clinical-evaluation/

https://blog.amwa.org/an-introduction-to-clinical-evaluation-reports-for-medical-writers

https://www.greenlight.guru/blog/top-imdrf-documents

https://www.imdrf.org/sites/default/files/2021-09/imdrf-cons-clinical-evaluation-kdc-190405.pdf

https://compliancenavigatorppd.bsigroup.com/en/medicaldeviceblog/Global-harmonization/

https://www.ebdiagnostics.org/center/sub_05_01_APEC_CoE_WS.do

https://www.federalregister.gov/documents/2016/10/14/2016-24805/software-as-a-medical-device-clinical-evaluation-international-medical-device-regulators-forum-draft

https://mdi-europa.com/updated-clinical-evaluation-guidance-on-comparability/

https://www.qualtechs.com/en-gb/article/280

https://www.mwe.com/insights/fda-issues-fourth-final-software/

https://www.donawa.com/wp-content/uploads/2019/06/EMDT-Jul-Aug12.pdf

https://www.hardianhealth.com/clinical/pre-market-clinical-evaluation-report

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices.html

https://decomplix.com/medical-device-clinical-evaluation-mdr/

https://www.medicept.com/comparing-uk-mhra-standalone-software-and-imdrf-software-as-medical-device-guidance-documents/

https://www.imdrf.org/sites/default/files/docs/imdrf/final/meetings/imdrf-meet-160913-brazil-working-group-update-samd.pdf

https://casusconsulting.com/imdrf-table-of-contents-june-2024-round-up-of-mdcg-guidance/

https://blog.johner-institute.com/regulatory-affairs/clinical-evaluation-of-software/

https://www.medical-device-regulation.eu/mdr-guidance-documents/

https://perfval.com/software-as-a-medical-device-samd-clinical-evaluation-and-validation/

https://www.apec.org/docs/default-source/satellite/RHSC/PWA-Documents/Medical-Devices/APEC-RHSCMDCore-Curriculum-2020-Oct.pdf

https://lne-gmed.com/wp-content/uploads/2022/03/GMED_Guide-Clinical_Evaluation_MDR-March2022.pdf

https://www.core-md.eu/wp-content/uploads/2023/11/P.Schnell-Inderst_CORE-MD_webinar_27.10.2023.pdf

https://www.makrocare.com/blog/imdrf-submission-format-for-medical-device/

https://www.tga.gov.au/resources/consultation/imdrf-consultation-proposed-update-document-post-market-clinical-follow-studies

https://www.emergobyul.com/news/imdrf-updates-guidance-global-regulatory-submissions

https://journal.emwa.org/medical-devices/clinical-evaluation-reports-6-years-after-the-introduction-of-meddev-271-revision-4/article/11810/clinical-evaluation-reports-6-years-after-meddev-27_1-revision-4.pdf

https://chinameddevice.com/imdrf-china/

https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation

https://www.pharmatomarket.com/imdrf-clinical-evaluations-clinical-investigations-and-clinical-evidence-for-medical-devices/

https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-gn-20-guidance-on-clinical-evaluation

https://www.jdsupra.com/legalnews/fda-announces-international-draft-26577/

https://arxiv.org/html/2411.00567v2

http://www.thema-med.com/en/2024/05/27/imdrf-pubblicata-guida-sui-principi-di-sicurezza-e-prestazione-dei-dispositivi-medici/

https://omcmedical.com/imdrf-guide-on-post-market-clinical-follow-up-studies-pmcf/

https://www.nemius.com/fileadmin/Redakteure/Downloads/MP-Recht/Internationale_Guides/IMDRF/1._IMDRF_technical_documents/Clinical_Investigation.docx

https://www.reddit.com/r/RegulatoryClinWriting/comments/1d23iwf/an_introduction_to_clinical_evaluation_reports/

https://www.nsf-prosystem.org/fileadmin/NSF-Prosystem/Dokumente/Downloads/Fachartikel/NSF-PROSYSTEM-Clinicial-evidence-for-medical-devices-and-IVDs.pdf

https://www.imdrf.org/sites/default/files/2021-09/imdrf-cons-mdce-pmcfus.pdf

https://bluegoatcyber.com/blog/imdrf-for-medical-devices-harmonizing-global-regulations/

https://www.greenlight.guru/blog/what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-medical-device-samd

https://mdlaw.eu/mdr/imdrf-latest-developments-towards-global-regulatory-harmonisation/

https://www.linkedin.com/pulse/navigating-nuances-clinical-evaluation-software-device-annamalai-sdx2c?trk=public_post

https://sequenex.com/samd-regulatory-pathways-a-step-by-step-guide-to-compliance/

https://andamanmed.com/wp-content/uploads/2023/11/for-consultation-gn-20-guidance-on-clinical-evaluation-2023-nov.pdf

https://mdrregulator.com/news/mhra-imdrfs-latest-guidance-on-ai-and-medical-device-software

https://www.nature.com/articles/s41746-025-01459-8

https://www.regulatoryrapporteur.org/medical-devices/understanding-key-components-of-a-clinical-evaluation/225.article

https://www.ropesgray.com/en/insights/viewpoints/102k48e/promoting-medical-device-regulatory-harmonization-key-takeaways-from-the-27th-im

https://sobelconsult.com/streamlining-clinical-evaluation-for-software-as-a-medical-device-best-practices-under-mdr-2017-745/

https://www.medtecheurope.org/wp-content/uploads/2020/05/clinical-evidence-requirements-ivdr-ebook-v3-medtech-europe-2023.pdf

https://www.raps.org/news-and-articles/news-articles/2025/1/imdrf-finalizes-good-machine-learning-practice,-so

https://www.ucl.ac.uk/therapeutic-innovation-networks/education-centre/devices-translation-roadmap/clinical-evaluation-devices

https://blog.seerpharma.com/software-as-a-medical-device-meeting-clinical-evidence-requirements

https://prorelixresearch.com/portfolio/software-as-a-medical-device-clinical-evaluation/

https://www.ebdiagnostics.org/center/download.do?ORG_NAME=1-1.pdf&SYS_NAME=1-1.pdf&mov_title=Lecture%20:%20Clinical%20evaluation%20and%20evidence%20for%20medical%20devices&idx=2

https://www.regdesk.co/imdrf-guide-on-adverse-event-reporting-terminology-details/

https://mann.usc.edu/wp-content/uploads/2021/11/Spring-2021-APEC-Symposium-Digital-Binder-Final-1.pdf

https://taylorandfrancis.com/knowledge/Medicine_and_healthcare/Medical_technology_%26_engineering/Global_Harmonization_Task_Force/

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html

https://www.standardsalliance-mdrc.org/wp-content/uploads/2022/09/Clinical-Presentation_Felicia-Haynes.pdf

https://www.sfda.gov.sa/sites/default/files/2020-03/MDS_G23.pdf

https://citemedical.com/imdrf-classification-to-apply-rule-11/

https://medinstitute.com/blog/3-steps-to-mdr-ivdr-compliant-systematic-literature-review/

https://emmainternational.com/the-international-medical-device-regulators-forum-imdrf/

https://pmc.ncbi.nlm.nih.gov/articles/PMC10276779/

https://ncto.ie/wp-content/uploads/2023/08/Toolkit-Regulatory-and-Clinical-Overview-2-1.pdf

https://nexialist.fr/en/mdcg-2020-6-regulation-eu-2017-745-clinical-evidence-needed-for-medical-devices-previously-ce-marked-under-directives-93-42-eec-or-90-385-eec-april-2020-2/

https://www.hardianhealth.com/regulatory/pre-market-clinical-evaluation-plan-cep

https://www.iso.org/obp/ui/%23iso:std:iso:14155:dis:ed-3:v1:en

https://topflightapps.com/ideas/samd-clinical-evaluation/

https://www.bsigroup.com/globalassets/localfiles/en-th/Medical%20devices/whitepapers/clinical-evaluation-under-eu-mdr-th.pdf

https://www.tga.gov.au/resources/consultation/consultation-software-medical-device-samd-clinical-evaluation

https://casusconsulting.com/clinical-evaluation-reports-cer-mdr-annex-xiv-part-a-structure-requirements/

https://www.interamericancoalition-medtech.org/regulatory-convergence/wp-content/uploads/sites/4/2024/04/5-DNM.pdf

https://www.federalregister.gov/documents/2017/12/08/2017-26441/software-as-a-medical-device-clinical-evaluation-international-medical-device-regulators-forum

https://www.emergobyul.com/news/imdrf-releases-key-guidance-documents-medical-device-software

https://link.springer.com/10.1007/978-3-030-98743-5_8-1

https://openregulatory.com/articles/clinical-evaluation-literature-review

https://www.sciencedirect.com/science/article/abs/pii/S1546144020310206

https://iris.who.int/bitstream/handle/10665/349093/9789240038462-eng.pdf

https://www.nationalacademies.org/event/10-29-2018/docs/DCBFF07896D0AB78FF8DECCF42D3E6015332C4A5CD67?noSaveAs=1