S4 Consumers and end- users

ESRS 2, SBM-3 Material impacts, risks and opportunities and their interaction with strategy and business model

The demographic trend of an ageing population, increasing chronic diseases and rapid technological development creates long-term opportunities for AddLife through growing demand for high-quality products, services and solutions that support more efficient healthcare systems. 

The sector is characterised by strict regulations and requirements related to product quality, safety, certifications, procurement requirements and compliance, where the new EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) are being implemented. Despite strict regulations, individual incidents with potentially negative impacts on patients and users cannot Always be avoided, for example if a product is defective or used incorrectly. As the Group’s advanced medical devices are often used in connection with diagnostics and clinical treatment, incidents may have serious consequences for individuals who are already in a vulnerable position due to their need for care or support.

AddLife’s assessment of impacts, risks and opportunities has been carried out as part of the double materiality analysis. The identified material impacts and the material opportunity have mainly been assessed at an aggregated level and based on the Group’s customers, patients and users in relation to AddLife’s overall product and service offering. No further in-depth analysis of specific groups of customers, patients or users has been deemed necessary.

S4-1 Policies related to consumers and end-users

In line with AddLife’s business model, the Group’s subsidiaries are responsible for their own operational business activities. This means, among other things, that work related to quality and product safety is managed locally. The majority of the Group’s subsidiaries have their own product safety policies as part of their quality management systems. These policies also form an integral part of their work to comply with the EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). At Group level, the commitment to comply with quality and safety standards is managed at an overall level through AddLife’s updated Code of Conduct, which was adopted by the Board of Directors after the end of the financial year. For more information about AddLife’s Code of Conduct, its content, related international frameworks and standards, and the responsibility for implementation, see “Code of Conduct and group-wide policies” in the chapter G1 Business conduct. In addition to this, there is no other group-wide policy that specifically addresses these matters.

S4-2 Processes for engaging with consumers and end-users about impacts

As a distributor, AddLife’s subsidiaries generally do not have direct contact with end patients and users. Instead, the subsidiaries engage in dialogue through customers and healthcare providers, contracting parties and industry organisations, which have good insight into the situation and perspectives of healthcare professionals, patients and users. AddLife strives for long-term business relationships and close cooperation with customers through the subsidiaries’ local sales organisations, which have strong knowledge of their respective business areas and markets.

Contact with customers and other counterparties takes place on an ongoing basis in various parts of the operations. AddLife acts as a strategic partner from the initial contact, throughout the entire procurement process, to the use of the products. The Group’s advanced products require qualified training, service and technical support for users and healthcare professionals, which is a central part of the subsidiaries’ operations.Through close and continuous dialogue with customers and other counterparties, feedback and needs are captured and used as a basis for improvements to products, services and ways of working. This, in turn, helps ensure safe, adequate and efficient use, provides support to healthcare professionals, patients and users, and ensures that solutions are well adapted to users’ needs.

S4-3 Processes to remediate negative impacts and channels for consumers and end-users to raise concerns

The subsidiaries handle any faults or defects through established quality procedures and complaint-handling processes. These processes comply with applicable legislation and relevant industry requirements, but may differ between subsidiaries. Such matters are normally handled by the subsidiary’s specialists in quality and product safety. If a fault or defect has been identified, the healthcare provider will usually submit a complaint to the subsidiary or the product supplier. In case of  serious incident where there is a risk of harm, affected patients may seek compensation, either from the manufacturer or the distributor, depending on who is legally responsible. However, such cases are rare in the European market. In addition to remediation, AddLife takes further actions in the event of identified deviations or complaints, as described in the section below.

The subsidiaries measure effectiveness in order to contribute to increased product safety and reliability in the Group’s products. Effectiveness is monitored on an ongoing basis through the follow-up of complaint handling, including analysis of root causes, handling times, recurring deviations and the corrective and preventive actions taken. The results are reported regularly to the management of each subsidiary.

In addition to local complaints-handling processes, both employees and external parties can report suspected irregularities, violations or offences via the Group’s whistleblowing channel. Whistleblowing cases are always handled in accordance with the formal process described in more detail under “Whistleblowing channel” in section G1 Business ethics.

S4-4 Taking action on material impacts on consumers and end-users, and approaches to managing material risks and pursuing material opportunities related to consumers and end-users, and effectiveness of those actions

AddLife’s subsidiaries work continuously to develop their offering of products and services in order to improve health, quality of life and access to care for patients and users. This means that the Group’s subsidiaries work systematically with quality and product safety. The work is largely governed by the sector’s strict regulations, which include requirements for structured risk assessment from a patient safety perspective, appropriate documentation and established procedures to stop sales or recall products where necessary. No group-wide initiatives have been carried out during the year and none are planned for the coming years, as issues relating to quality and product safety are managed as part of the subsidiaries’ regular operations.

In the event of a confirmed deviation, or when a complaint has been received that may give rise to a negative impact, a root cause analysis is carried out to identify the cause of the fault. Based on this, the corrective and preventive actions that are necessary and proportionate in the individual case are determined. These may include technical modifications to the product, updated customer information on safe use or, where required, product recalls and reporting to the relevant authorities in accordance with applicable regulations. For products where AddLife acts as a distributor, this is done in close cooperation with the supplier, while AddLife is responsible for the entire chain in respect of the subsidiaries’ own products. During the reporting period, AddLife did not provide any remediation to consumers or end users due to identified negative impacts.  

The effectiveness of actions and processes is monitored as part of the subsidiaries’ quality and risk management work, including the follow-up of incidents and complaints and recurring reviews of products and suppliers. This is done to ensure that identified issues are resolved on a lasting basis and that the processes for managing and, where applicable, remediating negative impacts on patients and users function as intended. During the reporting period, AddLife did not identify any serious human rights issues or incidents related to customers, patients or users.

The resources for managing the material impacts relating to customers, patients and users are located locally in the Group’s subsidiaries. These include dedicated resources, usually specialists in quality, product safety and regulatory affairs, as well as allocated budgets for training, audits, follow-up of complaints and deviations, and for the systems and processes required to ensure compliance with legal requirements.

S4-5 Targets related to managing material negative impacts, advancing positive impacts, and managing material risks and opportunities

The subsidiaries often have metrics and objectives as part of their quality management systems, with the aim of meeting the legal requirements on product quality set out in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The work and the objectives are followed up by the board of each subsidiary as part of local corporate governance, as well as by the relevant supervisory authorities through licensing procedures and inspections. On this basis, AddLife currently has no group-wide objectives for product safety and product quality.

In 2025, AddLife has conducted a project to develop a method for estimating the Group’s positive impact on patients and users. The method is planned to be tested in a pilot in 2026, after which the Group will evaluate whether, and in what form, group-wide objectives should be established in this area.