ARTICLE SUMMARY:
In a new guidance, European policymakers spell out responsibilities for mobile app marketplace owners, in particular Apple and Google, under the Medical Device and IVD Regulations, and other EU laws. Notably, the two tech giants contributed to the development of the document.
Apple and Google must take on EU regulatory responsibilities when selling medical device software (MDSW) from other companies on their mobile app marketplaces, EU policymakers affirmed in a June 16 guidance document.
MDSW makers have faced barriers with ensuring their products are being sold to patients in a regulatorily compliant manner and that they aren’t competing with software flouting Medical Device or IVD Regulation (MDR/IVDR) rules in third-party app stores. The new Medical Device Coordination Group guidance makes it clear that the purveyors virtual storefronts, in particular the App Store or Google Play, qualify as “intermediary service providers” under the EU Digital Services Act or as outright distributors or importers as defined in the MDR/IVDR. In either case, the platforms must ensure that they are selling compliant products and that their interfaces allow product safety labeling and other mandatory information to be clearly displayed. And when they are deemed distributors under the MDR/IVDR, tech companies must take even broader responsibility for compliance of apps sold on their platforms and for monitoring and reporting problems to authorities.
