CMR Evaluation Report for XXX Catheter XX导管CMR 评估报告-MDR.docx

File NO.:XXX CMR Evaluation Report for XXX Catheter Confidentiality: PAGE \* Arabic 2 / 9 File NO.:XXX CMR Evaluation Report for XXX Catheter Confidentiality: CMR Evaluation Report for XXX Catheter Status: Rev: A/0 Position Signature Date Draft: Process Engineer Review: Review: Approval: Content TOC \o "1-1" \h \z \u 1. Summary 2 2. Introduction 2 3. Method and Assessment process 2 4. Product Description 3 5. Product List 3 6. Raw Material……………………………………………………………………………………. 4 7. Classification Result 8 8. Further Risk Control 45 9. Conclusion 45 10. Attachment 45 Summary CMR requirement in Medical Device Regulation 2017/745 of the XXX Catheter has been performed. Medical Device Regulation 2017/745 risk assessment identifies areas of concern to be addressed by clinical exposure and testing. Testing strategies and or waiving of tests are developed using clear, concise, logical and scientifically reasoned plans for evaluating. It demonstrates that all CMR Medical Device Regulation 2017/745 hazards have been considered and relevant risks assessed and controlled. The XXX Catheter meets the requirements of Medical Device Regulation 2017/745 can be considered safe for the intended clinical use. Introduction Background Information Medical Device Regulation 2017/745 require shall only contain the following substances in a concentration that is above 0.1 % weight by weight (w/w),if CMR and/or endocrine-disrupting substances contained, justification shall be given. Guidelines Medical Device Regulation 2017/745. Method and Assessment process Product Description The XXX Catheter is used for lavage, spraying of solution by passing through a flexible endoscope working channel to the body's natural cavity such as gastrointestinal tract. Product List 1 XX 6 2 XX 7 3 XX 8 4 XX 9 5 XX 10 6. Raw Material No. Name Material Standard Suppiler 1.1 SUS304 GB/T xxx 1.2 SUS303 N/A 1.3 HDPE N/A 1.4 ABS757 N/A 7. Classification Result 7