2. Before placing on the market or putting into service an EHR system referred to in Article 26 or a wellness application referred to in Article 47, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall enter the required data as referred to in paragraph 4 of this Article into the EU database for registration of EHR systems and wellness applications, including, in the case of EHR systems, the results of the assessment referred to in Article 40.