certification Welcome to your certification Name Email 1. Sufficient clinical data means a significant number of sales in the last 5 years a confirmation letter from leading experts in the medical sector a significant number of animal studies addressing safety of the device the amount and quality of the clinical data and the clinical evaluation results which “allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits when used as intended by the manufacturer” None 2. Implantable devices are just devices which are intended to be totally introduced into the human body just devices which are intended to be totally introduced into the human body and remain in place after the procedure for at least 30 days devices which are intended to be totally introduced into the human body or are intended to replace an epithelial surface or the surface of the eye, by clinical intervention and remain in place after the procedure for at least 30 days devices which are intended to be introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device 3. The clinical evaluation assessment shall include an assessment of the promotional material including the proposed claims of the manufacturer just focus on the claims listed in the instructions for use None 4. The clinical benefit to be expected from a device shall be specified in the instructions for use Correct for devices with medical purpose Correct for devices without medical purpose It is not a requirement of the MDR None 5. The notified body shall None 6. A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be assumed on solely pre-clinical data relating to a device for which equivalence to the device in question can be demonstrated on clinical data relating to a device for which equivalence to the device in question can be demonstrated on sales data None 7. For implantable devices and class III devices it is not be possible to claim equivalence to a device certified with respect to the directives it is possible to claim equivalence to a device certified with respect to the directives None 8. A contract allowing full access to the technical documentation on an ongoing basis is required when applying the equivalence approach for Class III devices Non-Implantable class IIa and IIb devices Implantable devices regardless of their classification None 9. For non-implantable class IIa and IIb devices it is not be possible to claim equivalence to a device certified with respect to the directives it is possible to claim equivalence to a device certified with respect to the directives None 10. Considerations of whether a clinical dataset provides sufficient evidence that a performance endpoint has been met should include, where relevant, consideration of (tick all that apply) The magnitude and duration of treatment effect The percentage of the intended patient population achieving the intended benefit The cost-effectiveness of the treatment The validity of study design and statistical evaluation The appropriateness of the benchmark or control selected Outcomes achievable with other state of the art treatment options for the same intended patient population 11. “State of the art treatment options” refers only to similar devices with same intended purpose, and should not include alternatives such as medicines or physiotherapy True False None 12. Where a Notified Body has used external clinical experts to undertake a clinical evaluation assessment because it does not have sufficient clinical expertise in-house, internal reviewers must not challenge conclusions reached or recommendations made by these external experts True False None 13. Meeting all objectives described in a clinical investigation protocol with a p value < 0.05 for all relevant clinical endpoints does not necessarily mean that the manufacturer has adequately demonstrated safety and performance of their device True False None 14. Which of the following should be included in the manufacturer’s clinical evaluation plan? (tick all that apply) an identification of the GSPRs that require clinical evidence; a clear specification of intended patient populations including explicit indications and contra-indications; a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters; a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects; an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device; an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non- viable animal or human tissues, are to be addressed; a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a description of the PMCF with an indication of milestones and a description of potential acceptance criteria; 15. Where clinical evaluation is based on equivalence, a well designed PMCF study to demonstrate safety and performance should be considered, and is an explicit requirement for Class III and implantable devices True False None 16. It is never acceptable to demonstrate basic safety and performance of a device with non-clinical data True False None 17. Where benefit-risk cannot be established in relation to the state of the art, it may be possible to define a narrower intended patient population for which the device does demonstrate acceptable safety and performance in relation to the state of the art True False None 18. Which statements are correct PMCF is part of PMS PMS is part of PMCF PMCF is the proactive collection and review of experience of data gained by the device that is placed on the market PMCF is the proactive collection and evaluation of clinical data from the use in or on humans of a device that bears the CE mark within its intended purpose 19. A coronary stent gained market access via equivalence what is the most appropriate PMCF route? A prospective clinical study A prospective registry A scientific literature review No PMCF necessary None 20. What documents does the Notified body review for a post market clinical follow up study Clinical investigation protocol Clinical investigation report Informed consent Liability insurance certificates for the hospital CV of investigators All of the above None 21. A manufacturer of a TAVI submits a PMCF study for notified body review the indication for use of the CE marked device are limited to high risk patients, the manufacturer has included intermediate risk population in the inclusion criteria. Is this an appropriate PMCF study Yes No None 22. A PMCF study is indicated in which of the following circumstances The product is innovative The device treats a high risk target population There is unanswered questions regarding long term safety of the device CE marking was based on equivalence To expand the intended use to what has been previously considered off label use 23. A PMCF study is performed taking into consideration which of the following The study is performed within the intended use of the device Clearly stated research question, objective and related endpoints are outlined A plan to conduct the study according to appropriate standards, guidance and common specifications is compiled The plan should identify and justify the study population The plan should outline the inclusion and exclusion criteria 24. A PMCF study always requires competent authority approval Yes No None 25. A PMCF study is required for all devices Yes No None Time's up pascaleperspectives2025-02-20T13:13:09+01:00
