IVDR-TechnicalDoc Welcome to your IVDR-TechnicalDoc Name Email 1. According to Annex III is a Post market Performance follow-up plan required? Only for Class D devices For all devices It is not required for legacy devices None 2. When is consultation with an expert panel required? For all Class C & D devices For companion diagnostics For Class D devices where no Common Specifications exist and it is the first certification for that type of device None 3. According to Annex XIII is a performance evaluation report required? Yes it is required for every device May not be required if adequate justification is provided by the manufacturer A clinical performance study can be used instead None 4. According to Recital 66 of the IVDR, analytical performance studies should follow the guidance provided in ISO 20916:2019. Select one: True, ISO 20916:2019 is referenced in the IVDR so it should be applied for analytical performance studies False, Analytical performance studies are not in the scope of ISO20916:2019 False, IMDRF/IVD WG/N64FINAL:2021 should be used None 5. According to the IVDR, clinical evidence is based on the following elements (select all that apply) Analytical performance. NB assessment. Scientific validity. Clinical performance. A valid quality management system (QMS). 6. What is the required frequency of update of the Performance Evaluation Report (PER) for Companion Diagnostics devices? The IVDR does not specify any required frequency of update of the PER for any device class According to article 56, the PER for devices of the same class of the CDx should be updated when necessary, but at least annually According to article 56 the PER for devices of the same class of the CDx should be updated when necessary According to annex XIII 1.3. 2, the PER for devices of the same class of the CDx should be updated when necessary, but at least annually None 7. Which competency codes are NOT relevant for Technical Documentation assessments? IVR codes IVP codes IVS codes IVT codes IVD codes None 8. A manufacturer provides an application for 100 class C devices (Basic UDI-Dis). All devices are following into the same generic device group and the manufacturer established an individual Technical Documentation (TD) for each device. As per the MDCG document 2019-13, how many TDs have to be assessed by the NB prior issuing the certificate and during the initial certificate cycle respectively? Always 1 TD prior issuing the certificate + 15 TDs during the certificate cycle Always 1 TD prior issuing the certificate + 5 TDs during the certificate cycle At least 1 TD prior issuing the certificate + at least 5 TDs during the certificate cycle None 9. As per Annex VII IVDR section 4.5.4, the assessment of the performance evaluation part shall cover (please select all that apply): the intended use specified by the manufacturer and claims for the device the planning of the performance evaluation and the performance evaluation report all manufacturing specifications and process validations the methodology for the literature search and results Time's up pascaleperspectives2025-02-20T14:16:52+01:00
