Market Surveillance AuthorityAn authority designated by a Member State to ensure that systems comply with the EHDS primary-use requirementsIn short: Member States each designate a Market Surveillance Authority which is responsible to carry out activities carried and to take measures to ensure that products comply with the EHR Harmonized Component requirements.
The definition of 'market surveillance authority' is laid down in Article 3, of Regulation (EU) 2019/1020;
Organizational, Tasks(EHDS recital 47) In order to ensure there is appropriate and effective enforcement of the requirements and obligations laid down in this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 of the European Parliament and of the Council should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II of this Regulation or by a separate market surveillance authority responsible for EHR systems. While designating digital health authorities as market surveillance authorities could have significant practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.
Article 43 contains the details of the Market surveillance of EHR systems:
(EHDS recital 48) The staff of market surveillance authorities should have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, they should not be in a situation that could, directly or indirectly, affect the impartiality of their professional conduct. Member States should determine and publish the selection procedure for market surveillance authorities. They should ensure that the procedure is transparent and does not allow conflicts of interest. The tasks can be summarized as follows:
Oversee EU Database registrationsWhile the European Commission is responsible for managing and setting up the EU Database infrastructure, the Market Surveillance Authority's role is to ensure the validity and legality of the products listed within its jurisdiction. The market authority leverages the EU database to identify products on the market and verify that they meet the mandatory requirements for the interoperability and logging components.The Authority should identify updates that modify a system's original functions or increase risk, thereby triggering a necessity to renew the conformity assessment. Article 43(5): Where a manufacturer or another economic operator fails to cooperate with a market surveillance authority or where the information and documentation they have provided is incomplete or incorrect, the market surveillance authority may take all appropriate measures to prohibit or restrict the relevant EHR system from being made available on the market until the manufacturer or the economic operator concerned cooperates or provides complete and correct information, or to recall or withdraw such EHR system from the market. Monitor ConformityArticle 30(5): the Manufacturers of EHR systems shall, upon a reasoned request from a market surveillance authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements laid down in Annex II and the common specifications referred to in Article 36, in a language which can be easily understood by that market surveillance authority. The manufacturers of EHR systems shall cooperate with the market surveillance authority, at its request, on any measures taken to eliminate the risks posed by an EHR system which they have placed on the market or put into service.information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements laid down in Annex II and the common specifications referred to in Article 36, in a language which can be easily understood by that market surveillance authority. The manufacturers of EHR systems shall cooperate with the market surveillance authority, at its request, on any measures taken to eliminate the risks posed by an EHR system which they have placed on the market or put into service. Handle non conformanceMarket surveillance authorities have to take measures in the case of non-compliance by EHR systems. They should have procedures for identifying infringements, performing inspections, and applying penalties for non-compliance.Article 37(4): If the manufacturer does not comply with the requirements of [ .. ] this Article [to create technical documentation in the official language of the member state concerned], 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. The main articles related to non-conformance are:
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