Asphalion is pleased to share the release of the new MDCG guidance on the safe distribution of Medical Device Software (MDSW) apps on online platforms. This guidance provides important insights into the responsibilities of app platform providers under MDR/IVDR and the Digital Services Act. It aims to ensure that software, which supports crucial healthcare functions like insulin pump management and cancer diagnosis, meets required safety and transparency standards.
Key highlights include:
- Regulatory Roles: Defines when app platform providers are considered distributors or importers, subjecting them to MDR and IVDR requirements.
- Intermediary Services: Clarifies when providers act as intermediaries under the Digital Services Act, with obligations like risk assessment and cooperation with authorities.
- Compliance and Safety: Emphasizes ensuring that software apps meet stringent safety, performance, and data protection standards.
- Information Obligations: Details the necessity for clear, accessible information to patients, helping to differentiate between medical and non-medical apps.
Stay informed about how these regulations are shaping the future of medical device software in the EU market!
Read the full guide here: MDGC Guidance on MDSW
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