KCI Medical Belgium BV
Solventum
Solventum is a global life sciences company producing innovative products and services in sectors such as medical and surgical; dental; health data management and biopharma processing.
ID: 777082895009-31
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
Solventum welcomes the opportunity to submit this input, in response to the European Commissions public consultation on the targeted revision of EU rules for medical devices and in vitro diagnostics. Implementation complexity of the Medical Devices Regulation (MDR), inconsistent interpretations by Notified Bodies (NBs) and lengthy approval timelines are delaying patient access to critical technologies. In addition, there are systematic challenges related to the interplay between MDR, consumer and environmental legislation that need to be addressed. Provisions of EU consumer and/or environmental legislation create misaligned compliance requirements, regulatory duplication and inflated costs. In line with strategic goals to achieve regulatory simplification and improve European competitiveness, finding solutions for these regulatory challenges is essential. A few examples of such misalignments include unique identifier requirements duplication or the Right to Repair Directive, which conflicts with MDR rules specifying that only trained professionals may repair devices. Broader consumer and environmental frameworks (Ecodesign for Sustainable Products Regulation and Batteries Regulation) also apply by default to medical devices, increasing complexity and inconsistencies across Member States. This is especially critical given the growth in the use of medical devices in community settings under the direction of healthcare professionals. The shift in healthcare delivery from hospital to out-of-hospital care is vital to reduce the cost of care. Receiving professional care in the home environment is also generally preferred by patients. Patients living with diabetes, incontinence, stomas or recovering from major surgery are increasingly treated at home. They use professional medical devices under the direction of a medical professional, but they do so at home. Improving the interplay between the MDR and consumer legislation is crucial to unlock the potential of out-of-hospital care, improve patient outcomes and deliver more sustainable healthcare services. Electronic instructions for use (eIFU) is another important enabler to bring health care closer to communities and meet the patients preference for treatment at home. Solventum greatly welcomes the initiative of the European Commission to expand the provision for eIFU under the MDR. It helps to reducehealthcare costs, increase patient safety by providing healthcare professionals (HCPs) with rapid accessibility to the most updated information and contributes to sustainability goals. Solventum recommends expanding the ability to use eIFU for certain medical devices used by a lay-users in a community setting under the direction of a medical professional. Solventum urges the European Commission to: Exclude or derogate medical devices from overlapping consumer and environmental laws where MDR already provides sufficient safeguards; Establish clarity in the application of legislation, where MDR takes precedence for safety, labelling and material requirements specific to medical devices; Promote harmonisation and mutual recognition across EU legislation and among NBs to avoid redundant or conflicting obligations; Mandate cross-regulatory guidance to clarify how MDR-compliant products should meet requirements from environmental, chemical, and consumer legislation without duplication; Improve the EU mechanism for resolving conflicts and ensure clarification on interpretations is in place to reduce fragmentation across Member States; The use of eIFU should also be permitted for all medical devices intended for lay persons, including certain higher-risk devices, provided that appropriate safeguards are ensured. Such safeguards may include professional guidance during initial use and/or recurrent use that enables sufficient user familiarity.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
About Solventum: Solventum (registered as KCI Medical Belgium BV in the transparency register) is a global healthcare company originating from the spin-off of 3M's healthcare business in 2024. The company employs over 22,000 people globally and has an annual revenue of $8.3 billion in sales in 2024. The company employs over 5000 people in Europe and has seven manufacturing plants in the EU. Solventum offers a wide range of products and services, including medical solutions, oral care, health information and technology. The company focuses on creating products and services that improve patient outcomes, enhance healthcare delivery, and support healthcare professionals. on MDR: Solventum appreciates the opportunity to contribute to the targeted evaluation of the Regulation (EU) 2017/745 on medical devices (MDR) from the perspective of a company that has put many hundreds of products through the process. This contribution is also based on feedback from customers and users of the wide range of companys products. Solventum's position is complemented by the contributions from the EU trade associations, namely MedTech Europe and the German Medical Technology Association. Solventum suggests addressing the following issues: A: Revision of the existing five-year re-certification process The requirement to for recertification every five years presents a significant and unnecessary burden on the industry and. Additionally, it contributes to bottlenecks in notified bodies due to the lack of capacity, as they are already overstretched. Manufacturers who already have their certifications under MDR and are seeking recertification to renew their MDR certification must compete with those companies seeking first-time certifications of new products. , potentially leading to uneven access to certification. A one-time certification system for all devices would allow focus on the innovation of new products and alleviate the burden of the certification process. B. Increased Clinical Evidence Requirements The clinical evidence requirements have been increased under MDR. Technologies that have been on the market for many years with well-established safety profiles do not require new clinical research. The MDR needs to provide alternative pathways, such as conditional approval or enabling real-world data and real-world evidence to be used. C Measures to increase efficiency and introduce principles of good administration practice. The obligations for notified bodies under MDR and the overall administrative requirements have increased substantially. This has resulted in a significantly higher level of engagement being necessary from manufacturers. The primary purpose of the MDR is to provide a high level of safety for patients and users of medical devices, which is not in dispute. However, the significant bureaucratic burdens and delays in timelines may cause manufacturers to consider whether applying for certifications in the EU first is the right approach. As a result, the latest medical device innovations might be slow to reach patients in the EU. Industry needs a more predictable, streamlined and reliable certification process that is significantly faster and less expensive than the current one. Additional measures suggested: Enhancing transparency in the certification process can be achieved through more digitalization of the process. Increasing resources at notified bodies and process improvements will ensure faster and more reliable certifications processes. D electronic instructions for use (eIFU) Complementary to the topic of MDR is the promotion of digital solutions like electronic instructions for use (eIFU). They can improve the efficiency and sustainability of medical devices. Requiring a paper leaflet to accompany medical devices is in most cases unnecessary. Manufacturers provide extensive training to medical professionals in the application of their devices rendering the inclusion of a paper leaflet to be superfluous.
Read full responseResponse to Implementing regulation for electronic instructions for use for medical devices
21 Mar 2025
About Solventum Solventum (registered in the transparency as KCI Medical Belgium BV) is a global healthcare company originating from the spin-off of 3M's healthcare business in 2024. The company employs over 22,000 people globally and has an annual revenue of $8.3 billion in sales in 2024. The company employs over 5000 people in Europe and has seven manufacturing plants in the EU. Solventum offers a wide range of products and services, including medical solutions, oral care, health information and technology. The company focuses on creating products and services that improve patient outcomes, enhance healthcare delivery, and support healthcare professionals. On eIFU Solventum greatly welcomes the initiative of the European Commission regarding the expansion of the provision for electronic instructions for use (eIFU) under the Regulation (EU) 2017/745 on medical devices (MDR). This initiative will result in reducing healthcare costs will increase patient safety by providing healthcare professionals (HCPs) with rapid accessibility to the most updated information, and will contribute to sustainability goals. As a further enhancement to this digital regulatory solution, we strongly recommend that the use of eIFU not be limited to medical devices intended only for use by HCPs, but also to be permitted for medical devices used by laypersons under the supervision of HCPs. The latter represents a very large proportion of available medical devices whereby the impact of eIFU could be significant. In addition, manufacturers provide thorough training to HCPs on the use of their devices, making the inclusion of a paper leaflet largely unnecessary. The sustainability aspects of electronic instructions for use should not be underestimated. In many medical devices, the paper leaflet is the major contributor to weight of the product and the subsequent waste. Solventum acknowledges the Commission's activities as a major step towards aligning regulatory requirements with digital practices, allowing for reduced costs and administrative burdens whilst allowing for sustainable solutions and most importantly, better patient outcomes.
Read full response