EFPA contributes to the EC Call for evidence on EU rules on medical devices and in vitro diagnostics
About EU rules on medical devices and in vitro diagnostics – targeted evaluation.
EFPA contributes to the EC Call for evidence on EU rules on medical devices and in vitro diagnostics
EFPA contributes to the EC Call for evidence on EU rules on medical devices and in vitro diagnostics
The current regulation appears challenging for certain types of psychological interventions such as digital mental health apps. Such apps are often interventional in nature but, compared to other Class IIa medical devices, typically of comparatively lower risk.
This viewpoint has already been acknowledged outside of the EU, with the TGA in Australia, and MHRA and NICE in the United Kingdom considering dedicated regulation for digital mental health. In the EU context this would likely involve a combination of exempted classes of development as well as methods of assessment that are well matched for psychologically oriented tools for treatment, assessment and other forms of intervention.
Consideration should be given to the level of regulatory processes on the basis of risk posed in order to develop a right touch approach that balances safety with the need to encourage agile and inclusive development.
Read more here.