ANNEX XVI TEST Welcome to your ANNEX XVI TEST Name Email 1. Do all devices without an intended medical purpose fall under MDR? Yes No None 2. What is the deadline for a manufacturer with unchanged products marketed in the Union before 22 June 2023 conducting a clinical investigation to sign a contract with an NB? 26 September 2024 22 December2024 31 December 2026 31 December 2027 31 December 2029 None 3. What is the deadline for a manufacturer with unchanged products marketed in the Union before 22 June 2023 not conducting a clinical investigation to sign a contract with an NB? 26 September 2024 22 December2024 31 December 2026 31 December 2027 31 December 2029 None 4. What is the deadline for a manufacturer with unchanged products marketed in the Union before 22 June 2023 conducting a clinical investigation with a signed contract with an NB? 26 September 2024 22 December2024 31 December 2026 31 December 2027 31 December 2029 None 5. Does a device intended for tattooing fall under MDR? Yes No None 6. What is the classification of a high intensity electromagnetic radiation emitting equipment for skin treatment? IIa IIb III None 7. Which of the following Annex XVI devices were reclassified per CS 2022/2347? Contact lenses High intensity electromagnetic radiation emitting equipment for hair removal Equipment to reduce, remove or destroy adipose tissue Dermal fillers Brain stimulation devices to modify neuronal activity in the brain 8. A product (non medical, no MDD) which was placed onto the European Union market before 22 June 2023 and has no changes does not need an MDR application until 1 January 2027 or 1 January 2028 depending on no clinical or clinical investigation. True False None 9. A product (non medical, no MDD) which was not on the European Union market or has had changes cannot be placed onto the European Union market without MDR since 23 June 2023. True False None 10. Products without an intended medical purpose are covered under the MDR by: Rule 16 Article 16 Annex XVI None 11. If a device with no medical purpose is not covered by the six groups identified in Annex XVI of MDR then: NB can conduct review under the scope of MDR NB can request a Common Specification from the EU Commission for the device NB cannot accept the application for the device for non-medical purpose None 12. Equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of Annex XVI to Regulation (EU) 2017/745, is classified as: Class IIa Class IIb None 13. If the device is intended by the manufacturer only for a non-medical purpose, information supplied with the device shall not bear any clinical benefit claim or statement True False None 14. Implants and their accessories with no medical purpose are covered by the scope of eIFU Regulation 2021/2226. True False None 15. Clinical Evaluation Consultation Procedure (CECP) applies to Class III implantable Annex XVI devices True False None 16. Labelling and risk management requirements that are specific for Annex XVI devices can be found in the Annex XVI Common Specifications (Commission Implementing Regulation (EU) 2022/2346) in: Annex I only The relevant Annex for the device type (Annex II – VII) Both in Annex I and the relevant Annex for the device type (Annex II – VII) None 17. Devices without a medical intended purpose do have a clinical benefit. This statement is: True False None 18. The reason there is a strong focus of the Annex XVI Common Specifications 2022/2346 on labeling requirements is: Because all users will be medical professionals Because all devices will be used in controlled environments Because the devices may be used by people with very different levels of understanding and in uncontrolled environments Because E-labelling is not allowed for Annex XVI devices None 19. When there are specific risk controls measures identified for a device group in the Annex XVI Common Specifications 2022/2346, and a manufacturer already has such a device on the market: The manufacturer doesn’t need to implement the risk control measures if the device is already on the market A reassessment will need to be carried out by the manufacturer to determine if design changes are required in order to implement the require risk control measures The device should be completely redesigned by the manufacturer with a new design process in order to implement the required risk control measures None 20. When determining if a product qualifies as an Annex XVI device you should take into account: MDR 2017/745 Annex XVI Annex XVI Common Specifications 2022/2346 (“Whereas” and Annex II – Annex VII “Scope” requirements) MDCG 2023-5 Guidance on qualification and classification of Annex XVI Annex XVI products All of the above None 21. Classification of Annex XVI devices should be carried out by using: MDR Annex VIII only Commission Implementing Regulation (EU) 2022/2347 only MDR Annex VIII and Commission Implementing Regulation (EU) 2022/2347 None Time's up pascaleperspectives2025-02-20T14:19:22+01:00
