IVDR-CDx Conformity Assessment Training Welcome to your IVDR-CDx Conformity Assessment Training Name Email 1. Which of the following is correct: The intended purpose for CDx devices must include the INN and trade name of the medicinal product The intended purpose for CDx devices must include the trade name of the medicinal product The intended purpose for CDx devices must include the INN of the medicinal product None 2. The EMA guidance for CDx consultations is currently draft: True False None 3. The following channels for submissions to EMA are acceptable for the CDx consultation procedure: cdx_conslutations@EMA.com eSubmission Gateway eSubmission Web Client 4. EMA request the intention to submit letter X months in advance: 1 month 2 months Ad hock, no prior notification is required 3 months None 5. EMA expect the SSP to be provided within MDCG guidance 2022-9 – Summary of safety and Performance Template: True False None 6. Regarding Hazard ratios for the clinical performance study of the corresponding medicinal product: A hazard ratio of 0.97 for the corresponding medicinal product would likely support a CDx claim A hazard ratio of 1.40 for the corresponding medicinal product would likely support a CDx claim A hazard ratio of 0.32 for the corresponding medicinal product would likely support a CDx claim None 7. As part of the EMA CDx consultation guidance, pre-submission meetings are possible prior to the commencement of the consultation procedure, which of the following statements are true: The pre-submission meetings can only comprise EMA and Notified Body representatives The pre-submission meetings cannot include the marketing authorisation holder (MAH) Pre-submission meetings will always comprise a representative from the Pharmacovigilance Risk Assessment Committee (PRAC) Pre-submission meetings can be used to address timing and regulatory considerations Pre-submission meetings can include representatives from the medical device manufacturer Pre-submission meetings are triggered by a request from the marketing authorisation holder 8. What is the classification of a Companion Diagnostic medical device? Self-certified under IVDD and class C under IVDR Self-certified under IVDD and class B under IVDR Class C under IVDD and class C under IVDR Class B under IVDD and class B under IVDR None 9. What route to conformity applies for a CDx device? Annex IX Chapter I and III & Annex IX Chapter II Annex IX Chapter I and III & Annex IX Chapter II Section 5.1 Annex IX Chapter I and III & Annex IX Chapter II Section 5.2 Annex X & Annex XI 10. Up to 26 May 2022 IVDD certificates could be issued or renewed with an expiry date not going beyond 27 May 2025. The Date of Application (DoA) was 26 May 2022. With the staggered approach, IVD devices are also eligible to a grace period if a valid Declaration of Conformity has been issued under the Directive exist. What would be the end of the grace period for Companion Diagnostic devices that hold a valid IVDD certificate? 26 May 2024 26 May 2025 26 May 2026 26 May 2027 None 11. What is classification rule according to Annex VIII of the IVDR for Companion Diagnostic devices? Rule 1 Rule 3f Rule 4a Rule 6 None 12. The Notified Body will submit several documents to the EMA as part of the Consultation process. Which documents are to be submitted by the NB to EMA? EMA Application form, draft Summary of Safety & Performance (SSP), draft Periodic Safety Update Report (PSUR), draft Instructions for Use (IFU), draft Declaration of Conformity (DoC) EMA Application form, draft Summary of Safety & Performance (SSP), draft Periodic Safety Update Report (PSUR), draft Instructions for Use (IFU) EMA Application form, draft Periodic Safety Update Report (PSUR), draft Instructions for Use (IFU), draft Declaration of Conformity (DoC) EMA Application form, draft Summary of Safety & Performance (SSP) and draft Instructions for Use (IFU) EMA Application form, draft Summary of Safety & Performance (SSP), draft Instructions for Use (IFU), draft Declaration of Conformity (DoC) None 13. EMA has completed the consultation assessment and provided a negative scientific opinion back to the Notified Body. It is mandatory for a Notified Body to follow the opinion expressed by the Medical Products Authority when making its decision on whether or not the device is in compliance and a certificate can be issued. True False None 14. What are critical parameters within analytical performance? Target population Cutt-off value Specimen types CDx biomarkers All of the above None 15. What documentation should be shared with the drug agencies for an initial application: Performance evaluation report, SSP and IFU Performance evaluation report and SSP SSP and IFU None 16. Is “grandfathering” for Legacy Companion Diagnostics possible? Yes No None 17. Which of the following statements (a, b, c) is NOT IVDR compliant ? Companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to: Identify, before, and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product Identify, before, and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment Monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness None 18. The CDx Consultation is foreseen to have 2 rounds of review (60 days + 60 days), is a clock stop possible in case that the review is on hold (e.g. EMA needs additional clarifications of SSP and IFU)? Yes No None 19. Changes to a Companion Diagnostic can result in a supplement to the EU technical documentation assessment certificate and another consultation to the Medicinal Authorities. How much time has EMA for the issuance of the scientific opinion in this case? 30 days 60 days 90 days None 20. Which of the following statements is right: Currently, most Companion Diagnostic devices belong to oncology therapeutics Currently, most Companion Diagnostic devices belong to Cardiovascular therapeutics Currently, most Companion Diagnostic devices belong to Autoimmune therapeutics None Time's up pascaleperspectives2025-02-20T14:16:51+01:00
