Common specifications
1. By 26 March 2027, the Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements laid down in Annex II, including a common template and a time limit for implementing those common specifications. Where relevant, those common specifications shall take into account the specificities of medical devices and high-risk AI systems referred to in Article 27(1) and (2), respectively, including the state-of-the-art standards for health informatics and the European electronic health record exchange format. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. The common specifications referred to in paragraph 1 shall include the following information and elements:
(a)
their scope;
(b)
their applicability to different categories of EHR systems or functions included in them;
(c)
their version;
(d)
their validity period;
(e)
a normative part;
(f)
an explanatory part, including any relevant implementation guidelines.
3. The common specifications referred to in paragraph 1 may include elements related to the following:
(a)
datasets containing electronic health data and defining structures, such as data fields and data groups for the representation of clinical content and other parts of the electronic health data;
(b)
coding systems and values to be used in datasets containing electronic health data, taking due account of both potential future harmonisation of terminologies and their compatibility with existing national terminologies;
(c)
other requirements related to data quality, such as the completeness and accuracy of electronic health data;
(d)
technical specifications, standards and profiles for the exchange of electronic health data;
(e)
requirements and principles related to patient safety and the security, confidentiality, integrity and protection of electronic health data;
(f)
specifications and requirements related to identification management and the use of electronic identification.
4. EHR systems, medical devices, in vitro diagnostic medical devices and high-risk AI systems referred to in Articles 25 and 27 that are in conformity with the common specifications referred to in paragraph 1 of this Article shall be considered to be in conformity with the essential requirements covered by those common specifications or parts thereof, laid down in Annex II, and covered by those common specifications or the relevant parts thereof.
5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices, in vitro diagnostic medical devices or high-risk AI systems falling under other legal acts, such as Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, the adoption of those common specifications may be preceded by a consultation with the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board established by Article 65 of Regulation (EU) 2024/1689 and the European Data Protection Board (EDPB), as applicable.
6. Where common specifications covering interoperability and security requirements of medical devices, in vitro diagnostic medical devices or high-risk AI systems falling under other legal acts, such as Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, affect EHR systems, the Commission shall ensure that the adoption of those common specifications is preceded by a consultation with the EHDS Board and the EDPB, as applicable.
Technical documentation
1. Manufacturers shall draw up technical documentation before the EHR system is placed on the market or put into service, and shall keep that documentation up to date.
2. The technical documentation referred to in paragraph 1 of this Article shall demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. That technical documentation shall contain, as a minimum, the elements set out in Annex III and a reference to the results obtained from a European digital testing environment referred to in Article 40.
3. The technical documentation referred to in paragraph 1 shall be drawn up in an official language of the Member State concerned or a language that is easily understandable in that Member State. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into an official language of that Member State.
4. When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, the manufacturer shall provide such technical documentation or translation within 30 days of the date of the request, unless a shorter deadline is justified because of a serious and immediate risk. If the manufacturer does not comply with the requirements of paragraphs 1, 2 and 3 of this Article, the market surveillance authority may require it to have a test performed by an independent body at its own expense within a specified period in order to verify the conformity with the essential requirements laid down in Annex II and the common specifications referred to in Article 36.
Information sheet accompanying the EHR system
1. EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users.
2. The information sheet referred to in paragraph 1 shall specify:
(a)
the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
(b)
the name and version of the EHR system and date of its release;
(c)
the intended purpose of the EHR system;
(d)
the categories of electronic health data that the EHR system has been designed to process;
(e)
the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
3. As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system, manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of EHR systems and wellness applications referred to in Article 49.
EU declaration of conformity
1. The EU declaration of conformity referred to in Article 30(1), point (e), shall state that the manufacturer of an EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.
2. Where an EHR system is subject to other Union legal acts in respect of aspects not covered by this Regulation, which also require an EU declaration of conformity by the manufacturer in which it is stated that the fulfilment of the requirements of those legal acts has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union legal acts applicable to the EHR system. That EU declaration of conformity shall contain all the information required for the identification of the Union legal acts to which it relates.
3. The EU declaration of conformity shall contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member States in which the EHR system is made available.
4. Where an EU declaration of conformity is drawn up in a digital format, it shall be made accessible online for the expected lifetime of the EHR system and, in any event, for at least 10 years from the placing on the market or the putting into service of the EHR system.
5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the harmonised software components of the EHR system with the requirements laid down in this Regulation when it is placed on the market or put into service.
6. The Commission shall publish a standard uniform template for the EU declaration of conformity and make it available in a digital format in all official languages of the Union.
European digital testing environment
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).
CE marking of conformity
1. The CE marking of conformity shall be affixed visibly, legibly and indelibly to the accompanying documents of the EHR system and, where applicable, to the packaging of the EHR system.
2. The CE marking of conformity shall be affixed before placing the EHR system on the market.
3. The CE marking of conformity shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
National requirements and reporting to the Commission
1. Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems.
2. The national requirements or provisions referred to in paragraph 1 shall not adversely affect the harmonised software components of EHR systems.
3. When Member States adopt requirements or provisions in accordance with paragraph 1, they shall inform the Commission thereof.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
