EU Group Calls For Official Health App Assessments As Google And Apple Act As ‘De Facto Regulators’
The regulation of health and wellness apps in the EU and beyond should involve certification from a third-party organization, while proposed legislation on health data must align with the Medical Device Regulation, warns European Commission group Label2Enable.
You may also be interested in...
The European Commission’s proposed Regulation on the European Health Data Space has been broadly met with optimism by MedTech Europe. While some fine-tuning is needed, the trade body believes the initiative will help align health data across the EU.
The UK’s Medicines and Healthcare products Regulatory Agency will produce guidance determining which types of digital mental health tools should qualify as medical devices after receiving funding from charitable trust Wellcome.
The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted by the European Medicines Agency.