[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-352632-105":53,"doc-detail-352632-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","medical-device-coordination-group-document-mdcg-2020-7-post-market-clinical-follow-up-pmcf-plan-template","Medical Device Coordination Group Document MDCG 2020-7 - Post-market clinical follow-up (PMCF) Plan Template","","MDCG 2020-7 provides a template and guidance for developing a post-market clinical follow-up (PMCF) plan under Regulation (EU) 2017/745. 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The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.  \nMedical Device Coordination Group Document MDCG 2020-7  \nPost-market clinical follow-up (PMCF) Plan Template  \nA guide for manufacturers and notified bodies  \nMedical Device Coordination Group Document MDCG 2020-7  \nContents  \nIntroduction ...........................................................................................................................................................................................................................................4  \nPost-market clinical follow-up plan Template .................................................................................................................................................................................. 5  \nSection A. Manufacturer contact details....................................................................................................................................................................................... 5  \nSection B. Medical Device description and specification .......................................................................................................................................................... 6  \nSection C. Activities related to PMCF: general and specific methods and procedures........................................................................................................7  \nSection D. Reference to the relevant parts of the technical documentation ..........................................................................................................................9  \nSection E. Evaluation of clinical data relating to equivalent or similar devices.................................................................................................................... 10  \nSection F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s) .............................11  \nSection G.– Estimated date of the PMCF evaluation report .................................................................................................................................................. 12  \nMedical Device Coordination Group Document MDCG 2020-7  \nIntroduction  \nThe Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a plan, necessary to implement PMCF.  \nA PMCF plan shall specify the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from the use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.  \nThe aim of the PMCF plan is:  \n􀁸 confirming the safety1 and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime;  \n􀁸 identifying previously unknown side-effects and monitor the identified side-effects and contraindications;  \n􀁸 identifying and analysing emerg","cbCaidZYY4IB27LM","https://ap.wps.com/l/cbCaidZYY4IB27LM","pdf",722386,"English","# Introduction\n## Post-market clinical follow-up (PMCF) plan template\n## Section A. Manufacturer contact details\n## Section B. Medical Device description and specification\n## Section C. Activities related to PMCF\n## Section D. Reference to relevant parts of technical documentation\n## Section E. Evaluation of clinical data relating to equivalent or similar devices\n## Section F. Applicable common specifications and guidance documents\n## Section G. Estimated date of the PMCF evaluation report","[{\"question\":\"What is the role of the PMCF plan under MDR (EU) 2017/745?\",\"answer\":\"The PMCF plan is part of the manufacturer’s post-market surveillance plan and addresses updating the clinical evaluation through continuous post-market clinical follow-up.\"},{\"question\":\"What objectives must a PMCF plan address?\",\"answer\":\"It should confirm safety and performance (and clinical benefit if applicable), identify previously unknown side-effects, monitor side-effects and contraindications, analyze emergent risks with factual evidence, ensure benefit-risk acceptability, and detect systematic misuse or off-label use.\"},{\"question\":\"How are PMCF findings documented and assessed?\",\"answer\":\"Manufacturers analyze PMCF findings and document results in a PMCF evaluation report, which is part of the clinical evaluation report and technical documentation. The adequateness and application of the PMCF plan are assessed by the notified body.\"}]","Medical Device Coordination Group Document MDCG 2020-7 - Post-market clinical follow-up (PMCF) Plan Template | PDF",1790100559]