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1. The Commission shall develop a European digital testing environment for the assessment of harmonised software components of EHR systems. The Commission shall make the software supporting the European digital testing environment available as open-source.

2. Member States shall operate digital testing environments for the assessment of harmonised software components of EHR systems. Such digital testing environments shall comply with the common specifications for the European digital testing environment laid down pursuant to paragraph 4. Member States shall inform the Commission about their digital testing environments.

3. Before placing EHR systems on the market, manufacturers shall use the digital testing environments referred to in paragraphs 1 and 2 of this Article for the assessment of harmonised software components of EHR systems. The results of that assessment shall be included in the technical documentation referred to in Article 37. The elements in relation to which the results of the assessment are positive shall be presumed to be in conformity with this Regulation.

4. The Commission shall, by means of implementing acts, lay down the common specifications for the European digital testing environment. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).