Article 104Amendment to Regulation (EU) 2024/2847

Regulation (EU) 2024/2847 is amended as follows:

(1)

in Article 13, paragraph 4 is replaced by the following:

‘4. When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts, the cybersecurity risk assessment may be part of the risk assessment required by those Union legal acts. Where certain essential cybersecurity requirements are not applicable to the product with digital elements, the manufacturer shall include a clear justification to that effect in that technical documentation.’

(2)

in Article 31, paragraph 3 is replaced by the following:

‘3. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.’

(3)

in Article 32, the following paragraph is inserted:

‘5a. Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council (*1) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.