Google's and Apple's tightrope walk between enforcement and oversight as distributors and developers for healthapps tudresden_de NaturePortfolio
In addition to being distributors, if a medical device app was developed outside the EU, app stores are also effectively functioning as “importers”, which invokes substantial further requirements. Importers must be established in the EU, and while Apple and Google do have subsidiary entities, their role with respect to the EU MDR is unclear. Importers must also ensure that instructions for use are made available and that apps are correctly registered in EUDAMED.
These dilemmas are relevant in the light of two closely linked recent EU laws, the Digital Markets Act and the Digital Services Act
Belgique Dernières Nouvelles, Belgique Actualités
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