On the basis of the New Legislative Framework, as clarified in the Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’, the general rule is that more than one legal act of Union harmonisation legislation, such as the MDR and the IVDR and the DSA, may be applicable to one product, since the making available or putting into service can take place only when the product complies with all applicable Union harmonisation legislation.
Taking into consideration the definitions set out in the MDR and IVDR (some of which are outlined in section 2 of this document), the upload of a MDSW app by a manufacturer corresponds to the “placing on the market”. The time during which the MDSW app is available via the app platform provider corresponds to the “making available on the market” accordingly.
Where an app platform provider is making its own MDSW available to users/patients, the app platform provider fully qualifies as an economic operator in the distribution chain of that medical device