Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices
Event
Human
Medical devices
- The original event time is:
- Wednesday, January 25, 2023 - 14:00 - 15:30 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
EMA is launching a pilot to provide scientific advice to manufacturers of certain high-risk medical devices.
As per Article 61(2) of Regulation (EU) 2017/745 on medical devices, the expert panels may give scientific advice to manufacturers of some high-risk medical devices on their intended clinical development strategies and proposals for clinical investigations.
This advice covers class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body.
Starting at the end of February, the agency will be accepting letters of interest from companies that would like to be considered for the pilot.
The European Medicines Agency is offering this open event to provide:
- background on the scientific advice pilot including the purpose, the timing and the prioritisation criteria for the pilot,
- description of the pilot process,
- information on the letter of interest and the submission portal.
On 25 January, the EMA with the participation of the European Commission held an information session webinar on the pilot project for expert panels’ scientific advice to manufacturers of high-risk medical devices. The event had the remote participation of nearly 400 attendees. A series of presentations were given covering the following topics:
- Commission measures for continued availability of safe medical devices,
- EMA’s role in medicines and medical devices,
- Background to the Scientific Advice from the Expert Panels,
- Introduction to the pilot on Scientific Advice from the Expert Panels,
- Submission Portal for the Scientific Advice from the Expert Panels.
Following the presentations, there was a Q&A session with the audience where questions regarding the scope of the advice, the application process, the prioritisation criteria and the submission portal were addressed.