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.
Following the presentation, an interactive Q&A session is provided to address questions.