Consumers and end-users

Strategy

Stakeholder interests and perspectives
AddLife has not yet conducted direct dialogue with patients and end-users at the group level. The group's subsidiaries primarily communicate with hospitals, elderly care facilities, and similar stakeholders, although some subsidiaries that sell directly to consumers maintain some level of dialogue with patients and users. However, this part of the group's business is very limited and occurs mainly within the Homecare business unit.

Material impacts, risks, and opportunities and their relationship to strategy and business model
AddLife's consumers and end-users mainly consist of patients and care recipients. They access the group's products and services through hospitals, nursing homes, or laboratories, or through research enabled by AddLife. Additionally, AddLife distributes products used in veterinary medicine and the food industry.

AddLife does not sell products that are inherently harmful or that increase the risk of chronic diseases. However, AddLife provides monitoring products for elderly care, which could pose a potential privacy risk if data security is compromised. Users of these products are a particularly vulnerable stakeholder group, as they are often elderly or ill.

For all products in the group's portfolio, accurate usage and maintenance information is essential, as regulated by EU legislation. These products are typically used by trained personnel on behalf of consumers or end-users, reducing the risk of misuse. Products used directly by patients or users are generally easy to handle and primarily consist of assistive devices for the elderly and people with disabilities.

All identified negative impacts on users and patients are linked to individual incidents where a product was either defective or used incorrectly. AddLife has not identified any systematic negative impacts. All products sold by AddLife aim to improve people's lives. The group's diverse product portfolio covers several therapy and diagnostic areas. The group's customers are primarily in Europe, but some products are also distributed internationally.

There is a potential financial risk associated with product liability that is significant enough to be considered material but does not require specific measures at the group level. Product safety efforts are regulated by EU legislation and are a core part of the subsidiaries' operations. More information on this is provided in the section Managing Impacts, Risks, and Opportunities. At the same time, there are also material business opportunities linked to product responsibility. AddLife's business model is based on creating positive impacts for people, which itself constitutes a financial opportunity for AddLife.

As part of the group's materiality analysis, AddLife is actively working to identify which consumers and end-users may be particularly vulnerable to risks related to the group's products and services. Currently, AddLife is conducting an analysis to deepen its understanding of how specific groups may be negatively affected, as well as the potential risks and opportunities that exist. In collaboration with relevant business area managers, AddLife is reviewing existing data and processes to ensure a more comprehensive assessment.

Managing impacts, risks, and opportunities

Policies for consumers and end-users
AddLife does not currently have a group-wide policy specifically for consumers and end-users, but such a policy will be developed in 2025 or 2026. However, the group's subsidiaries have their own policies to comply with legal requirements.

The In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR) require that all organizations selling such products document their management of product quality, which applies to most of the group's subsidiaries. Many of them use management systems such as ISO 9001 or ISO 13485 to support their work with product quality, including policies related to consumers and end-users.

In 2024, AddLife began updating its Code of Conduct to align it with the UN Guiding Principles on Business and Human Rights, the ILO Declaration on Fundamental Principles, and the OECD Guidelines for Multinational Enterprises. The revised Code of Conduct will be published in 2025, outlining the group's commitment to respecting human rights across its value chain.

In 2025, AddLife will develop a policy and guidelines on how the group will engage in dialogue with vulnerable stakeholders and handle remediation of negative impacts. This work will also cover consumers and end-users, although the initial focus will be on workers in the supply chain.
AddLife has not identified any cases of non-compliance with the UN Guiding Principles on Business and Human Rights, the ILO Declaration on Fundamental Principles, or the OECD Guidelines for Multinational Enterprises in relation to consumers and end-users.

Procedures for contact with consumers and end-users regarding impacts
To manage its impact on consumers and end-users, AddLife collaborates with healthcare professionals and customers to gain insights into consumer perspectives. This collaboration is primarily reactive and occurs when issues arise, such as product defects. Specialists within the group's subsidiaries handle these matters directly with customers to quickly address problems and continuously improve products. Despite this reactive approach, AddLife ensures that all issues are handled immediately.

Responsibility for this collaboration lies with the group's subsidiaries, where specific roles oversee the complaint handling process. The subsidiaries measure effectiveness by tracking how well complaints are managed, including root cause analysis and the implementation of corrective actions. For serious incidents, AddLife reports to authorities and issues guidelines for safe use or recalls products if necessary. This approach ensures that consumer feedback is effectively integrated into the group's processes, contributing to improved product safety and reliability.

AddLife is currently conducting an analysis to deepen its understanding of how specific groups may be negatively impacted, including potential risks and opportunities. In collaboration with relevant business area managers, AddLife is reviewing existing data and processes to ensure a more comprehensive assessment.

Procedures for remediation of negative impacts and channels for consumers and end-users to report issues
At present, AddLife does not have a group-wide process for handling remediation of identified negative impacts. In 2025, AddLife will develop a policy and guidelines defining when and how remediation should be provided.

However, a complaint-handling process is in place for products that do not function as expected and could negatively affect consumers and end-users. Typically, the group's customer (i.e., healthcare providers) report complaints—rather than individual patients or users.

When a complaint is submitted, it is logged in an internal system, and the customer is contacted to determine whether the issue was a product deviation or a customer request. If the issue is confirmed, a root cause analysis is conducted, followed by planning and implementation of corrective and preventive measures. Once these measures are verified, the case is closed, and a final response is sent to the customer. Any defects are also reported to the relevant authorities in the country where the product is used, typically by healthcare professionals.

If a product malfunctions and causes harm, affected patients may seek compensation either from the manufacturer or the distributor, depending on whom they hold responsible. Such cases are rare in Europe, which is AddLife’s primary market.
AddLife measures the effectiveness of its complaint-handling process by tracking how well complaints are resolved, including root cause analysis and the implementation of corrective actions. For serious incidents, AddLife reports to relevant authorities and takes measures such as clarifying safe usage guidelines or, if necessary, recalling products.

Patients and end-users can report concerns via AddLife's whistleblowing channel. However, AddLife assesses that awareness of the channel is low among these groups, as the group does not have a direct relationship with them but instead reaches them through its subsidiaries' customers.

Currently, AddLife does not have an established method to increase awareness of the whistleblowing channel or to evaluate trust in it among patients and users. However, AddLife knows that its customers (healthcare providers) have a high level of awareness and trust in the process for handling defective products, as it is legally required and well-established within the industry.

Measures regarding material impacts on consumers and end-users and strategies to manage material risks and leverage material opportunities for consumers and end-users, and the effectiveness of these measures
AddLife does not currently have a group-wide action plan specifically for consumers and end-users. However, the group's subsidiaries have implemented measures to prevent, mitigate, and manage negative impacts on consumers and end-users to comply with IVDR and MDR regulations. Regular product risk classifications from a patient safety perspective and an annual review of documentation, including CE marking, ensure that products meet MDR and IVDR regulatory requirements.

The manufacturer conducts the product risk classification, and the scope varies depending on whether the product is intended for internal or external use. During product distribution, the subsidiaries ensure that proper documentation is available. When subsidiaries manufacture the products themselves, they are responsible for conducting the product risk classification. If the required documentation is missing, the product is withdrawn from sale. Risk classification occurs at least once per year, with follow-up analyses conducted for marketed products, ensuring that all material aspects are considered.

For products not covered by IVDR or MDR, the group's subsidiaries apply general quality management practices, often in accordance with ISO 9001 or similar standards, thereby minimizing risks that could negatively impact patients and users.
The subsidiaries have also introduced processes to ensure that user manuals are available in local languages to support correct product usage. Additionally, they have established traceability systems to enable product identification and, when necessary, product recalls in case of detected defects.

When actual negative impacts occur, they are addressed through a complaint-handling process, where the causes are investigated, and corrective actions are implemented, including halting sales if necessary. For more information on this process, refer to the sections above. The subsidiaries continuously work to identify and introduce new products that can have a positive impact on people's lives and that are in demand by the group's customers.

The effectiveness of these measures is evaluated through annual supplier follow-ups, risk assessments, and post-market assessments. These include product studies and complaint reviews to ensure that products function as intended, and manuals are updated as necessary.

If a product does not perform as expected and could negatively impact a patient or user, the group's subsidiaries use a structured process to identify and implement necessary actions. Through a detailed root cause analysis, the cause of the issue is determined, allowing for the definition and implementation of corrective and preventive actions based on the nature of the problem.
For distributed products, the supplier is always involved, taking the case forward and assuming responsibility for any corrective actions. For products produced by AddLife, the group takes full responsibility for the remediation process. This may require updating risk assessments or modifying the product design or instructions to prevent the issue from recurring. For additional details on complaint handling and remediation, see the sections above.

The most significant financial risk affecting the group's patients and users arises if the group or its suppliers fail to meet MDR or IVDR requirements. Such a failure could potentially lead to increased costs for certain parts of the group, though the likelihood is assessed as low. It is particularly unlikely that such costs would be significant enough to have a material financial impact at the group level.

Overall, this risk is not considered serious enough to necessitate specific measures, although AddLife continues to monitor developments. The group's subsidiaries take this risk seriously and actively work within their respective operations to ensure continued compliance with regulations.

AddLife continually works to identify new business opportunities that could have a positive impact on patients and end-users. The group's subsidiaries independently drive this work by developing new products or increasing sales of existing products that improve patient and user quality of life. At the same time, the parent company supports its subsidiaries in this work through AddLife's ownership governance, ensuring strategic and coordinated development across the group.

No cases of serious human rights violations or other incidents related to patients and users have been reported during the year. However, a number of minor incidents have been identified and addressed within the complaint-handling process outlined above.

Metrics and targets

Goals for managing material negative impacts, strengthening positive impacts, and addressing material risks and opportunities
AddLife does not currently have group-wide targets related to consumers and end-users, even though this is one of the group's more strategic sustainability issues. The reason for this is the complexity of estimating the group's potential positive and negative impact on patients and users. However, some of the group's subsidiaries have product quality targets, which to varying degrees relate to consumers and end-users, as part of their quality management systems. 
During 2025 and 2026, AddLife plans to develop a methodology to estimate the group's positive impact on patients and users, with the aim of establishing a group-wide target. However, this work is complex, as the group's subsidiaries collectively distribute approximately eighteen million unique products, meaning that the process will be carried out step by step.
The goal for positive impact will be complemented by key performance indicators (KPIs) to enable tracking of both potential negative and positive impacts.
Currently, AddLife does not monitor the effectiveness of policies and measures related to patients and users at the group level. Instead, follow-ups are conducted within each subsidiary's quality management efforts and their preparations to comply with IVDR regulations.