Summary
Medical Device Coordination Group guidance on making medical‑device software apps available through online platforms, explaining when platforms act as distributors and associated duties for CE/UDI verification, traceability, and incident communications.
Healthcare Implications
Developers must ensure compliant listing, labeling, vigilance routes, and rapid takedown; platforms clarify responsibilities; hospitals can update allow‑lists and procurement checks for AI‑enabled health apps reaching clinicians or patients.