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IVDR’s Summary of Safety and Performance

Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasise transparency and provide adequate public access to summarise the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable.<br>

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IVDR’s Summary of Safety and Performance

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  1. IVDR’sSummaryofSafetyand Performance(SSP) WWW.MAVENPROFSERV.COM

  2. Overview EnsuringCompliance:UnderstandingTheIVDR’sSummaryOfSafetyAnd Performance(SSP) WhatIsSummaryOfSafetyAndPerformance(SSP)? WhyIsSummaryOfSafetyAndPerformance(SSP)Important? WhatResourcesAreRequiredForSummaryOfSafetyAnd Performance(SSP)Preparation? WhatLanguagesShouldTheSummaryOfSafetyAndPerformance(SSP) Provide?

  3. Ensuring Compliance: Understanding The IVDR’s Summary Of Safety And Performance (SSP) The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasize transparency and provide adequate public access to summaries the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable

  4. ThispostwillunpacktheSummaryofSafetyandPerformance (SSP),explainingwhatitis,whyitmatters,andwhatitcontains.

  5. WhatIsSummaryOfSafety AndPerformance(SSP)? The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasize transparency and provide adequate public access to summaries the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable

  6. The data presented in the Summary of Safety and Performance (SSP) is compiled directly from the technical documentation. EU IVDR requires the Summary of Safety and Performance (SSP) to be validated by a Notified Body (NB), updated annually with new information and made available to the public via EUDAMED.

  7. WhyIsSummaryOfSafety AndPerformance(SSP)Important? It increases transparency by makingdata onthe IVD’s performancepubliclyavailable. By havingthisinformation readilyavailable,healthcare professionals can make more informed decisions about usingIVDintheirpractice.

  8. For certain IVDs, the Summary of Safety and Performance (SSP) can empower patients to understand the test better andparticipateinshareddecision-makingwiththeir healthcareprovider.

  9. What Resources Are Required For Summary Of Safety And Performance (SSP) Preparation? Summary of Safety and Performance (SSP) relies on already gathered information and technical documentation such as designanddevelopment,riskmanagement,performance evaluation,post-market performance follow-upand post- marketsurveillance.

  10. MDCG 2022-9 provides guidance for the preparation of the Summaryof Safety andPerformance (SSP),whichhastwo sections: fordevicesintendedtobeusedbyprofessionals fordevicesintendedforself-testing

  11. Summary Of Safety And Performance (SSP) For Devices Not IntendedForSelf-Testing: Itincludestwosubparts:oneforprofessionalusersand another for patients/laypersons. If it is decided that a patient version/layperson is not applicable, then a justification must be provided.

  12. SummaryofSafetyandPerformance(SSP)shallinclude: Deviceidentificationandgeneralinformation Intendeduseofthedevice DeviceDescription ReferencetoanyharmonisedstandardsandCS Risksandwarnings Summaryofperformanceevaluationandpost-marketperformancefollow-up

  13. Metrologicaltraceabilityofassignedvalues Suggested profile and training for users RevisionHistory Summary of Safety and Performance (SSP) is not intended to replace Instructions for Use as the maindocument to ensure safe use of the device, nor is it intended to provide diagnostic or therapeuticsuggestionstointendedusers.

  14. What Languages Should The Summary Of Safety And Performance (SSP) Provide? Summary of Safety and Performance (SSP) should be prepared in languages accepted in the Member states, where the device is to be sold, along with an English version of the document. The language inwhich the Summary of Safety and Performance (SSP)wasvalidatedwillbementionedinthedocument.

  15. ContactUs https://mavenprofserv.com/understanding-the-ivdr- summary-of-safety-and-performance/ business@mavenprofserv.com enquiry@mavenprofserv.com

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