How do the increased clinical evidence requirements impact

Reference no: EM133669352

Discussion Post

For this discussion board, I'd like for you to build upon the device you picked for DB#4, where you completed the GSPR checklist. Since this week focuses on changes to the clinical evidence requirements under MDR/IVDR, please prepare a well-researched response (1-2 pages with adequate citations & APA references) that addresses the following: Provide a gap analysis on the required clinical evidence required for your chosen product. Based on the classification of your device and amount of clinical evidence available, how do the increased clinical evidence requirements impact your product? Will you need to perform additional clinical investigations or clinical data collection in order to meet the general safety and performance requirements? (MDCG 2020-06 Appendix III) If yes, detail what type of activities and the estimated cost/timeline to complete. If no, discuss why the amount of clinical evidence available is acceptable (using MDCG 2020-06 APPENDIX III). Based on your assessment in "A", provide an analysis on the business impact that the new clinical evidence requirements will have on the manufacturer's ability to continue to sell this product in the EU. Do you recommend that the business continue with plans to CE-mark this product under MDR/IVDR?

Reference no: EM133669352

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How do the increased clinical evidence requirements impact : Based on the classification of your device and amount of clinical evidence available, how do the increased clinical evidence requirements impact your product?

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