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Zimmer Biomet Holdings

ZBH

Zimmer Biomet (NYSE: ZBH) is a publicly traded medical device company.

Lobbying Activity

Response to Digital package – digital omnibus

10 Oct 2025

Zimmer Biomet, a global leader in medical technology, supports the European Unions digital ambitions and shares the European Commissions objective to foster innovation that benefits patients and health systems. In healthcare, connected medical technologies enable personalized prevention, faster diagnosis, and patient-specific treatments. Data generated by medical devices are part of the intended use under the Medical Devices Regulation (MDR). The MDR sets robust, comprehensive requirements for product design, patient safety, and security. When horizontal digital rules apply on top of MDR obligations, alignment is essential to safeguard patient access to high-quality, modern devices while avoiding unnecessary administrative burden. Today, medtech companies operate in a dense and fragmented framework of EU digital legislation. It includes the Artificial Intelligence (AI) Act, the Data Act, the European Health Data Space (EHDS), and the General Data Protection Regulation (GDPR). While each instrument pursues legitimate and important policy goals, their combined effect can create overlapping, duplicative, and sometimes inconsistent obligations. Divergent implementation and enforcement across EU Member States further compound legal uncertainty, delay deployment, and divert resources from innovation and patient care. Zimmer Biomet welcomes the opportunity to contribute feedback to the Digital Package on Simplification. We support a bold, coherent, and innovation-friendly approach to digital regulation. The goal must be to streamline and clarify interactions between horizontal digital laws and sector-specific requirements. Simplification is not about lowering standards; it is about making compliance more efficient, predictable, and practicable. This will help ensure that safe, effective innovation reaches European patients and health systems faster.
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Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

Zimmer Biomet, a global leader in medical technology, has always supported the good intentions of all parties to implement the EU Regulation 2017/745 on medical devices (MDR) as smoothly as possible within the defined transition period. However, despite extensive efforts, the system is not functioning in its intended robust, transparent, predictable and sustainable way that maintains safety and supports innovation. The slow and staggered roll out of MDCG guidance and regulation amendments is insufficient in addressing the systemic challenges of the new regulatory system. In practice, manufacturers are required to invest significantly more effort in documentation, often fulfilling duplicative requirements across multiple reports and forms. This diverts critical resources away from bringing valuable clinical innovations to European patients and healthcare professionals, undermining the regulations core objective. Bold, immediate measures and a comprehensive reform are necessary now to achieve an efficient and attractive CE marking system for all medical devices. We welcome the opportunity to offer feedback to inform the targeted revision of MDR and would like to highlight several areas where administrative requirements could be streamlined to reduce unnecessary burden, while maintaining patient safety and regulatory oversight. Zimmer Biomet strongly encourages that improvements are adopted without delay, as the faster these measures are implemented, the more effectively the system can support patient access and innovation. Several actions proposed, particularly those related to re-certification, require urgent attention to prevent the recurrence of a certification backlog and supply disruption. We fully support the use of implementing acts, guidance documents, and formal legislative reform to achieve the below explained objectives.
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Meeting with Hildegard Bentele (Member of the European Parliament)

25 Sept 2025 · Digital Omnibus

Meeting with Andrea Wechsler (Member of the European Parliament)

24 Sept 2025 · EU Industry Policy

Meeting with Andreas Glück (Member of the European Parliament)

17 Sept 2025 · Medical Devices

Meeting with Michael Mcnamara (Member of the European Parliament)

19 Mar 2025 · EU Medical Device Regulation

Meeting with Aurelijus Veryga (Member of the European Parliament)

18 Feb 2025 · Industry Perspectives and Challenges in Light of Recent Regulatory Developments in the Health and Chemical Sectors

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

18 Feb 2025 · Medical devices regulation

Meeting with Tom Berendsen (Member of the European Parliament)

14 Feb 2025 · Work visit

Meeting with Andreas Glück (Member of the European Parliament)

5 Dec 2024 · MDR

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

4 Dec 2024 · Medical Devices Regulation

Meeting with Andrea Wechsler (Member of the European Parliament) and Pharma Deutschland e.V

3 Dec 2024 · EU Environmental Policy

Meeting with Victor Negrescu (Member of the European Parliament)

2 Dec 2024 · Medical device regulation

Meeting with Martin Hojsík (Member of the European Parliament, Shadow rapporteur)

15 Nov 2024 · OSOA, REACH