Recital 42

Certain software components of EHR systems could be considered medical devices under Regulation (EU) 2017/745 or in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (16). Software or modules of software which fall within the definition of a medical device, in vitro diagnostic medical devices or an artificial intelligence (AI) system considered to be high-risk (the ‘high-risk AI system’) should be certified in accordance with Regulations (EU) 2017/745, (EU) 2017/746 and (EU) 2024/1689, as applicable. While such products are required to fulfil the requirements under the respective Regulation governing those products, Member States should take appropriate measures to ensure that the respective conformity assessment is carried out as a joint or coordinated procedure in order to limit the administrative burden on manufacturers and other economic operators. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device, an in vitro diagnostic medical device, or a high-risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system. In such case, the provisions on common specifications for EHR systems should be applicable to those medical devices, in vitro diagnostic medical devices and high-risk AI systems.