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Confindustria Dispositivi Medici

CDM

Confindustria Dispositivi Medici, member of Confindustria confederation, is the National Trade Association of companies of Medical Devices and Biomedical Tecnology Sector, in their wider meaning, coherently with European Sectorial Regulation and National Legislations definitions, and with the product ATECO coding assigned by Confindustria as organizational competence and representativeness criteria.

Lobbying Activity

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

24 Oct 2025 · Exchange of views on the reform of the medical devices regulation and follow-up on certain technical matters raised in the context of the call for evidence for the targeted revision of EU rules on medical devices.

Response to EU cardiovascular health plan

12 Sept 2025

Confindustria Dispositivi Medici represents Medical Devices sector in Italy. CVD are a major challenge for health systems, not only for mortality and disability, but also for their economic and social burden. Europe needs a CVH Plan aligned with national strategies, reshaping prevention, diagnosis, treatment and long-term care, with patients at centre and ensure sustainability. Atrial fibrillation is rising fast. We need comprehensive solutions to protect patients, reduce pressure on health systems, and realise a healthier Europe. Venous and peripheral vascular diseases also deserve greater attention, due to their impact on quality of life and possible complications. The Plan calls for a major shift in approach: fragmented, episodic, and hospital-centred responses no longer suffice. An integrated multidimensional strategy is needed: 1) prevention at the heart of public health, 2) stronger hospitals-community services links, 3) modern resource allocation, 4) reflect complexity of patient care pathways. Patient journey must be reimagined through technology, organisational redesign and cultural awareness. Prevention and health promotion are central. CVD are often linked to modifiable risk factors (hypertension, diabetes, high cholesterol, obesity, smoking, sedentary habits). Uniform and consistent CV screening and preventive programs should be introduced where missing. Recent medical guidelines recommend that patients suffering of severe aortic stenosis should benefit from treatment regardless of symptoms: early detection becomes even more critical. Structural Hearth Disease (SHD) screening via heart checks should be ensured. EU funding should support MS in developing dedicated community-based and in-hospital screening programs for SHD, leveraging digital and AI solutions applied to Big Data. Digitalization and full implementation of EHR are indispensable to collect reliable data, demand assessment and plan dynamic and evidence-based interventions. Digital technologies need to be relevant in this strategy also to engage citizens in a process of personal responsibility and awareness. Remote monitoring using inbuilt algorithms of implanted devices can help early diagnosis in case of disease progression and should be consistently part of disease management. This and other Breakthrough Implantable Devices, such as minimally invasive valve repair or replacement and pulsed field cardiac ablation, are first-in-class solutions that address unmet medical needs, offer more effective treatment, or can help tackle major public health challenges, easing pressure on healthcare systems. They free resources such as staff time and hospital beds, increase longevity, reduce burden on health and long-term care systems. EU CVH Plan should promote action to improve EU access pathways for early evaluation, adoption, procurement and funding of such innovations. Stronger hospitals-community services link is needed. Countries should create clear, consistent, and measurable diagnostic-therapeutic pathways, helping clinicians act with confidence and coherence across system. Reimbursement must take centre stage in the proposal. We need to rationalise resource allocation and recognise long-term value of innovation: better outcomes, fewer hospitalisations, and greater efficiency. It's time to move beyond siloed budgets. Pathology-based evaluation system can align spending with epidemiological trends and patient needs. Gender equity has not to be neglected. Integrating gender perspective into CVH policies would reduce disparities and improve interventions effectiveness, tailored to biological and social characteristics of patient. The Plan should not be just technical recommendations, but a broader reform vision of CVD management: shifting from reactive response to acute crises, toward proactive, patient-centred and system-wide strategy. EU CVH Plan offers a strategic opportunity to boost patient access, drive innovation, strengthen European MedTech sector.
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Response to Revision of the 'New Legislative Framework'

2 Sept 2025

Confindustria Dispositivi Medici welcomes the European Commission initiative to revise the New Legislative Framework (NLF). This initiative is vital for keeping the European Market strong as a driver of economic growth, innovation, and resilience. Our more detailed recommendations for the aspects to be considered in the evaluation are outlined in the attached document. Confindustria Dispositivi Medici fully support simplification as the main driver of the NLF revision. Confindustria Dispositivi Medici is the main trade association in Italy, which units, represents and enhances companies in the medical device and in vitro diagnostic sector. Through its technologies, products, and processes, the medical device industry plays a vital role in improving patient care, streamlining healthcare delivery, and easing the workload of medical professionals. It is an essential pillar of our healthcare systems and a key contributor to addressing the challenges of the future. For further details, Confindustria Dispositivi Medici has published a dedicated position paper on this, available here: https://www.confindustriadm.it/position-paper-revisione-mdr-ivdr/
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Response to Establishment of an expert panel on orphan and paediatric devices

16 Jun 2025

Confindustria Dispositivi Medici (CDM), the Italian trade association for the MD and IVD industry, warmly welcomes this initiative and acknowledges the effort put in place by the European Commission in further enhancing the activities of the expert panels, with the inclusion of a dedicated expert panel for paediatric and rare disease. We suggest including in the implementing act an explicit declaration that this expert panel will cover both medical devices and in vitro diagnostic devices, to ensure that experts in both areas will be part of the expert panel. In the description of the expert panel scope, we suggest adding rare clinical use to include those devices that, other than be used for common diseases, are used in special clinical situations for which their use is considered critical and not systematic. Confindustria Dispositivi Medici is the trade association in Italy, which units, represents and enhances companies in the medical device sector, including diagnostics, digital health, medical imaging, radiotherapy, electromedical industries, borderlines, and complex and hearing aids. It represents over 500 companies, from start-up and small-medium enterprises up to multinationals and plays a vital role in advancing innovation in the health technology space. For more information, please contact quality.regulatory@confindustriadm.it.
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Meeting with Antonella Sberna (Member of the European Parliament)

5 Jun 2025 · Il ruolo delle tecnologie per la salute, il contributo dell’industria al sistema sanitario europeo e la necessità di un quadro normativo più efficace per garantire innovazione, accesso e qualità delle cure.

Meeting with Giorgio Gori (Member of the European Parliament)

23 Apr 2025 · Presentation of the federation and views on upcoming revision of sector-related legislation

Meeting with Stefano Cavedagna (Member of the European Parliament)

9 Apr 2025 · Introductory meeting

Meeting with András Tivadar Kulja (Member of the European Parliament)

8 Apr 2025 · Medical device sector challenges

Response to Implementing regulation for electronic instructions for use for medical devices

20 Mar 2025

Confindustria Dispositivi Medici acknowledges the effort and this specific initiative put in place by the European Commission on the matter of electronic instruction for use for medical devices. Indeed, we are favorable to the update of the Regulation (EU) 2021/2226 proposed by the European Commission, as the expansion of the electronic instructions for use (eIFU) to all medical devices intended for exclusive use by healthcare professionals will enhance accessibility, searchability, and adaptability for the professional users. Looking ahead, in the rapidly evolving digital landscape, creating a more eco-friendly, paperless, and efficient healthcare system is crucial. Further digitalization is vital for boosting Europes competitiveness, simplifying processes, and reducing the administrative burdens of both MDR and IVDR. Providing medical devices equipped with eIFU when they are intended for professional use will significantly help reduce paper waste and enable manufacturers to streamline their processes, delivering devices quicklier. As a general consideration regarding future perspectives, for the medical device sector additional digitalization efforts should be also considered, such as providing eIFU and electronic patient information leaflets (Art. 18, points b to d) to lay users, particularly in cases where they are trained by a professional. While for the in-vitro diagnostic (IVD) sector, Confindustria Dispositivi Medici supports the extension of the eIFU to IVDs for professional use intended for near-patient testing. As regard the current draft, we would like to propose some implementations, detailed in the attached document. The main suggestions we would like to see as improvements of the actual draft focus on: 1. the inclusion of Annex XVI devices used by professionals in the scope of Regulation (EU) 2021/2226. 2. The consideration for not automatic exclude from the scope of the Regulation (EU) 2021/2226 those devices used both by healthcare professionals (HCPs) and lay users, particularly when the medical device is directly provided from the HCP to the lay users (e.g., contact lenses). 3. A comprehensive revision of the requirement regarding tracking of the users who download the eIFU and the requirement about updating of all historical versions of the eIFU. 4. Defining with more clarity the requirements related to the URL of the eIFU. 5. Defining with more clarity the application to the eIFU to legacy devices. The attached document describes in detail the above listed suggestions. About Confindustria Dispositivi Medici Confindustria Dispositivi Medici is the trade association in Italy, which units, represents and enhances companies in the medical device sector, including diagnostics, digital health, medical imaging, radiotherapy, electromedical industries, borderlines, and complex and hearing aids. It represents over 500 companies, from start-up and small-medium enterprises up to multinationals and plays a vital role in advancing innovation in the health technology space. For more information, please contact quality.regulatory@confindustriadm.it
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

Confindustria Dispositivi Medici (CDM) welcomes the European Commissions initiative on the targeted evaluation of both medical devices (MDR) and in vitro diagnostics regulation (IVDR). We understand and support the general principles and process of the better regulation that MDR and IVDR are going through and we acknowledge the work already done or put in place (2025 secondary legislation initiatives) by the European Commission to alleviate the short-term implementation of MDR and IVDR. MDR and IVDR were designed to enhance safety, transparency and innovation in the field of medical devices by creating a more robust, transparent, predictable and sustainable system. However, our members are still experiencing negative effects from the structural issues of the regulatory infrastructure. These issues are related to delays in the regulatory infrastructures (Eudamed, EURLs for IVDs to mention few) or to lack of harmonisation among parties, unpredictability, complexity and costly regulatory pathways for CE marking. CDM, together with its members, elaborates a detailed analysis of the effects of MDR and IVDR on the market, focusing on both European and Italian contexts, highlighting challenges and opportunities of improvements. We also include a series of proposals aimed at improving efficiency, governance, and innovation pathways within the regulatory system. These aim to uphold the existing high standards of patient and user health, as established by the current provisions of the MDR and IVDR, while looking at pragmatic implementation of the whole system. To complement the content of the attached document, in 2024 CDM conducted a survey within its members (full result at https://www.confindustriadm.it/risultati-survey-transizione-mdr-ivdr/). While the recent extension of the transitional period was welcomed, it has increased the administrative burden, for example with the notified body confirmation letter and the transfer of the appropriate surveillance. Furthermore, almost 42.5% of the respondents will discontinue the devices because the revenues are not enough to justify the MDR/IVDR certification cost, that remains one of the main challenges together with the long and unpredictability in the conformity assessment procedures and in the change management. This is resulting in a loss of attractiveness of the EU market and in the decision from many Italian manufacturers to not prioritize the EU as a first-launch market. MDR and IVDR have undoubtedly raised the bar for safety and quality in the European medical technology sector. However, the increased complexity, costs, and unpredictability associated are creating significant challenges for manufacturers, particularly SMEs, and are slowing down the pace of innovation in Europe, risking also the availability of long-standing legacy devices. To ensure that Europe remains a global leader in medical technology, it is essential that the regulatory framework is reformed to reduce administrative burdens, improve the efficiency of the certification process, and support the rapid development and marketing of new technologies. By streamlining the certification process, establishing clear timelines, and improving governance, Europe can create a regulatory environment that supports innovation while maintaining the high standards of safety and performance that patients and healthcare professionals expect. About Confindustria Dispositivi Medici Confindustria DM is the trade association in Italy, which units, represents and enhances companies in the medical device sector, including diagnostics, digital health, medical imaging, radiotherapy, electromedical industries, borderlines, and complex and hearing aids. It represents over 500 companies, from start-up and small-medium enterprises up to multinationals and plays a vital role in advancing innovation in the health technology space. Data from the Italian market at https://www.confindustriadm.it/il-settore-in-numeri-2024/
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

18 Mar 2025 · Courtesy meeting with the new leadership of the trade association, discussion on the latest developments in the medical devices sector and upcoming events

Meeting with Flavio Facioni (Cabinet of Commissioner Olivér Várhelyi)

5 Mar 2025 · Medical devices regulatory framework

Response to Unique Device Identifiers for spectacle frames, spectacle lenses and ready-made reading spectacles

27 Feb 2025

Confindustria Dispositivi Medici welcomes the European Commissions efforts in the implementation of the regulatory infrastructure of Regulations (EU) 2017/745 and 2017/746 and the possibility of providing comments at this specific initiative on Master UDI-DI (MUDI). We, as Italian trade association representing medical device industry, fully support the goals of the UDI system to ensure the traceability of devices in Europe. However, we do not agree with the proposed implementation of the MUDI, since this is in contrast with the ambition of a global UDI system. This latter is a system adopted in various jurisdictions in the world, and it is founded on the principles defined by the International Medical Device Regulators Forum (IMDRF), according to which the UDI system shall be implemented to provide a single, globally harmonized system for positive identification of medical devices. With this system, patients and healthcare professionals shall be able to rely on a single, complete source of information in identifying a medical device and its key attributes. In particular, regarding the draft of this delegated regulation: i. the proposed implementation of the MUDI represents a regulatory solution over a database or technical solution to handle UDI data for devices with numerous variants. As a result, key aspects (e.g., integrity, consistency, granularity, structure, and governance) are being managed within the EU UDI system independently from the global framework, rather than being technically integrated into EUDAMED. This decision creates a disadvantageous divergence from the internationally established UDI systems. Furthermore, we believe that the practical implications of managing a large number of UDI-DIs or using an alternative identifier, such as the MUDI, have not been thoroughly assessed in Europe to justify the conclusion that the MUDI is the most suitable solution. ii. The MUDI, as proposed, will no longer identify the type of device uniquely. The current UDI system provides a detailed granularity for the unambiguous identification of devices by assigning a globally unique device identification number for a device. The MUDI represents a homogenization of UDIs that lead to the loss of the last levels of granularity and, consequently, of the unambiguous identification of the unique devices. iii. Implementing the MUDI will impact logistical and supply chain processes if an enlarged UDI-carrier will be necessary on the label of the device to carry the MUDI, since economic operators and users could not have the possibility to scan and read this modified UDI-carrier. The proposed additional UDI-PI are basically clinical sizes, and do not represent a production identifier. Adding this information in the UDI carrier, in an enlarged barcode, may impact the readability and generate more difficulties for the patient to identify the clinical size of the device reported on the label. iv. The concept of MUDI is being expanded beyond contact lenses, to other product categories. This is further increasing the amount of information (e.g., clinical sizes) excluded from EUDAMED and transferred in UDI-PIs. The possible consequences are the drawbacks regarding patient safety, manufacturing and supply chain processes, and disconnection from the rest of the global UDI system. For these reasons, Confindustria Dispositivi Medici is not in favour of the implementation of Master UDI-DI systems and its progressive extension to further categories of medical devices. About Confindustria Dispositivi Medici Confindustria is the trade association in Italy, which units, represents and enhances companies in the medical device sector, including diagnostics, digital health, medical imaging, radiotherapy, electromedical industries, borderlines, and complex and hearing aids. It represents over 500 companies, from start-up and small-medium enterprises up to multinationals and plays a vital role in advancing innovation in the health technology space.
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Response to Single Market Strategy 2025

30 Jan 2025

Confindustria is the main trade association in Italy, which units, represents and enhances companies in the medical device sector, including diagnostics, digital health, medical imaging, radiotherapy, electromedical industries, borderlines, and complex and hearing aids. It represents over 500 companies, from start-up and small-medium enterprises up to multi-national ones and plays a vital role in advancing innovation in the health technology space. Confindustria Dispositivi Medici welcomes the European Commissions efforts to update the Single Market Strategy. This initiative is vital for keeping the Single Market strong as a driver of economic growth, innovation, and resilience. It ensures that businesses can expand and that EU citizens can make the most of the opportunities available across the region. For these reason, we are submitting the attached feedback aiming at considering the importance of a strong single-market approach also for medical devices in Europe.
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Meeting with Brando Benifei (Member of the European Parliament)

10 Jul 2023 · Green Claims Directive

Meeting with Aliénor Margerit (Cabinet of Commissioner Paolo Gentiloni)

23 Mar 2022 · CBAM/Taxation issues