Team size: Eight

What factors influence your team’s decision to use external legal services versus handling matters in-house, and what criteria are used to evaluate their performance?

Our core principle is to maximise the utilisation of our in-house capabilities. The decision to engage with external counsel is driven by specific, well-defined needs. Primarily, we seek external support when a matter demands specialised expertise not currently available within our team’s broad skill set (e.g., highly niche areas of law, complex matters we don’t cover daily, or novel regulatory interpretations). Secondly, resource constraints, particularly acute time pressures where internal bandwidth is insufficient to meet critical deadlines without compromising quality or core responsibilities, necessitate external partnerships. Thirdly, significant litigation or large-scale, multi-jurisdictional transactions sometimes require the additional manpower and specific litigation/transactional bench strength that top-tier firms provide.

When selecting and evaluating external legal advisors, we employ stringent criteria: demonstrated, leading-edge knowledge and proven track record in the specific area of law relevant to the mandate; understanding of our business objectives, risk tolerance, and corporate culture. Proximity and a strong working relationship with the specific partner and team are crucial; clear fee structures, efficiency in execution, and strict adherence to agreed budgets are paramount. We prioritise firms offering innovative fee arrangements; timely updates, clear and concise advice, proactive identification of issues, and accessibility are essential; ability to provide pragmatic, solution-oriented advice aligned with commercial realities, not just theoretical legal positions; and, seamless coordination across relevant jurisdictions for matters requiring multi-country support.

How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact?

The Portugal Legal Hub functions as a strategic enabler deeply integrated into the company’s business strategy, serving both as a Center of Excellence providing cross-border legal expertise and as an embedded partner proactively guiding commercial initiatives. We anticipate challenges and structure opportunities that align directly with corporate objectives.

A recent initiative from the Portuguese Legal Team powerfully demonstrates this strategic leadership: our response to Decree-Law No. 29/2024, April 5, which mandated Portuguese-language interfaces for in vitro medical devices in Portugal. This regulation presented a critical challenge, as healthcare professionals in Portugal routinely and effectively use these devices with English-language interfaces without reported safety or usability issues.

Requiring immediate Portuguese localisation would have caused a major and significant operational disruption across the industry. It would have necessitated extensive, costly product modifications by companies, potentially delaying or limiting Portugal’s access to the latest innovative medical technologies – an outcome with negative implications not just for our business, but for Portuguese healthcare providers and patients reliant on cutting-edge diagnostics.

Recognising the severe potential impact on business continuity, patient access, and market innovation, our team mobilised immediately upon identifying the regulatory shift through our continuous monitoring. We convened a dedicated task force involving regulatory affairs, country management, and stakeholders from different areas and countries to formulate a unified strategy. We meticulously documented the technical and logistical barriers to immediate full localisation, proposed realistic phased compliance timelines, and submitted a compelling formal exemption request grounded in clinical necessity and the established safe use of English interfaces by qualified professionals. Within some months, this focused effort resulted in INFARMED granting a formal derogation, permitting the continued use of English-language interfaces while full localisation plans were developed.

What are some of the biggest legal or regulatory challenges currently facing your industry, and how is your team preparing to address them?

Our industry is experiencing a period of accelerated regulatory evolution, marked by a growing complexity of legal frameworks and increasing expectations from regulators, stakeholders, and the public. Among the most significant legal and regulatory challenges we currently face are those related to digital transformation, innovation, and compliance.

Some of the most pressing examples include the European Union’s Artificial Intelligence Act, the Medical Device Regulation (MDR), constantly evolving data protection requirements, ESG-related legal obligations, and the growing impact of digital and cybersecurity legislation. Each of these areas presents not only compliance demands but also strategic implications for how we develop, deliver, and position our products and services in the market.

The EU AI Act, for instance, introduces a novel risk-based framework that classifies AI systems and imposes stringent compliance obligations, particularly for high-risk applications – including many AI-powered medical devices. For companies operating in the medical technology sector, this presents significant challenges in interpreting how AI-driven functionalities in devices are categorised, aligning product development and regulatory strategies accordingly, and ensuring compliance across multiple jurisdictions. The overlap with existing frameworks such as the Medical Device Regulation (MDR) adds further complexity, requiring careful coordination between regulatory, legal, and technical teams.

To address these complex and evolving challenges, our legal team has adopted a forward-looking, collaborative, and structured approach. As part of a larger global legal function, we benefit from a broad base of legal expertise across different areas, including regulatory law, compliance, data privacy, commercial law, and litigation. This diversity enables us to be both proactive and responsive.

We have established dedicated practice groups—cross-functional teams composed of legal professionals with complementary expertise and backgrounds—focused on key thematic areas such as Collaborations and Strategic Partnerships, Corporate, Digital Offerings, and others. These groups serve as internal centers of excellence that monitor developments, conduct legal analyses, and share insights and best practices across jurisdictions.

At Siemens Healthineers we take a strong interest in ensuring that the team is not only legally sound but also strategically aligned with the company’s goals. To that end, we are continuously investing in our people—enhancing their legal knowledge, developing soft skills, and fostering a culture of learning and agility. We participate in regular internal training, legal updates, and external conferences. Where relevant, we collaborate with external counsel, regulators, and industry groups to gain insights and advocate for practical, balanced regulatory frameworks.

Importantly, we also focus on embedding legal risk awareness within the business. We work closely with operational teams to ensure that legal and compliance considerations are integrated early in the decision-making process. This proactive engagement helps reduce risk, increase efficiency, and support innovation in a way that is legally robust and ethically sound.

In what ways does your legal team promote diversity, equity, and inclusion, both within the department and in your external legal partnerships?

The Legal HUB composition inherently reflects our commitment to DE&I, with members of diverse backgrounds, nationalities, genders, sex and ages. Several team members play active leadership roles within the broader SEU Zone (Southern Europe – Italy, Portugal, Spain, Greece) DE&I initiatives. This commitment to fostering an inclusive environment extends to our selection and evaluation of external legal partners.