On 18 and 19 October 2017, the JRC hosted the first workshop with EU competent authorities on approaches and processes for signal detection and management for medical devices.
More than 30 representatives from 20 Member States, as well as from Switzerland and Norway, attended.
With about 700 000 to 1 000 000 medical devices on the EU market, regulators are in dire need of effective systems and methods to actively monitor pre- and post-market safety data to identify possible risk signals, patterns and trends.
Signal detection is a complex problem touching on topics such as signal theory, statistical methods, data quality and management as well as operational and process aspects including database functionalities.
Workshop attendees agreed with JRC's proposal to 'dissect' the problem into seven modules to build an "Open Conceptual Framework" (OCF) of signal detection and to develop this framework in a series of workshops.
Other key agreements include:
- definition of signal in the medical device area,
- key elements of a risk assessment-based approach for qualitative signal detection,
- importance of data sources and their differential use depending on the specific device in question.
- Data publicării
- 31 octombrie 2017