This info session aims to overview the current status of the implementation in Belgium of the EU Clinical Trials Regulation (CTR) and the Medical Devices Regulation (MDR).
The CTR entered into force on 16 June 2014, but its date of application is dependent on the availability of the EU portal and database (CTIS), which has been postponed several times and is now planned for Dec 2021 at the latest. In the meantime, Belgium has published its Law on clinical trials (7 May 2017) and the FAMHP is actively participating in the beta testing of the CTIS. In addition, the CTR Pilot initiative was launched, allowing sponsors to file a Clinical Trial Application (CTA) that will be assessed according to the principles of the CTR/new Law (joined review by the FAMHP and the designated Ethics Committee), but within the timelines of the still applicable CT Directive/Law on experiments. This will allow all stakeholders to gain experience with the new procedure. CTR Pilot applications can also include CTAs according to the Voluntary Harmonised Procedure (VHP) Plus. Both these procedures will be discussed in more detail.
The MDR will be applicable as of 26 May 2020, without indication that this date will be postponed. In Belgium, the regulatory authorities are preparing a specific Law concerning its local implementation. The current thinking about this implementation will be discussed in more detail.
By the end of this TRIUM Training you should be able to:
- Briefly describe the specificities of the CTR/Law on clinical trials, and the main differences with the Clinical Trials Directive/Law on experiments
- Understand the process of the CTR pilot project, including the VHP Plus, and be able to prepare a CTA accordingly
- Summarize the current thinking about the implementation of the MDR in Belgium
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.