Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.

By Marcelo Trevino, independent expert

The medical technology sector in Europe is undergoing significant regulatory transformations, particularly in Switzerland and the U.K. These changes are shaping how medical devices are approved, marketed, and monitored. For medtech professionals, staying informed is not just about compliance, it's about ensuring business growth, securing market access, and embracing innovation in an increasingly complex regulatory environment.

Switzerland is working toward reestablishing its relationship with the European Union (EU) while exploring new avenues, such as recognizing FDA-approved devices. Meanwhile, the U.K. is rebuilding its regulatory framework post-Brexit, emphasizing UKCA marking, strengthening post-market surveillance, and positioning itself as a global hub for AI-driven medical technologies.

Understanding these regulatory shifts and their implications is critical for anyone operating in the medtech space. This article dives into the latest developments in both Switzerland and the U.K., offering clear explanations and actionable strategies for navigating these evolving landscapes.

Switzerland’s Regulatory Crossroads: Reclaiming Market Access And Embracing New Pathways

Switzerland’s medtech industry has long been a powerhouse in Europe, with over 1,400 companies contributing to global innovation. Notably, 95% of these companies are small and midsize enterprises, which means that regulatory complexity can have a disproportionate impact on business operations. For years, Switzerland benefited from mutual recognition agreements (MRAs) with the EU, allowing Swiss manufacturers to access the European market with minimal barriers.

However, everything changed in May 2021, when negotiations between Switzerland and the EU broke down. As a result, Switzerland was classified as a third country for medical devices, meaning it lost its automatic access to the EU market. This development introduced significant regulatory hurdles and increased costs for Swiss manufacturers.

Manufacturers were suddenly required to appoint an EU-based Authorized Representative (AR) for their devices and ensure additional documentation and compliance processes. This has resulted in increased costs, longer timelines for approvals, and, in some cases, companies opting to leave the Swiss market due to the complexity.

The impact of this regulatory shift has been profound. Smaller companies, in particular, have struggled with the additional burden of dual regulatory compliance, meeting both Swiss and EU requirements. Foreign manufacturers also have been hesitant to maintain operations in Switzerland, particularly when dealing with lower-volume products that cannot justify the higher costs of compliance.

Switzerland’s Strategy For Regaining Market Competitiveness

Despite these challenges, Switzerland has been proactive in seeking solutions to maintain its competitive edge. One of the key initiatives is the effort to update the MRA with the EU. Negotiations resumed in March 2024, concluding by the end of the year. Negotiations between Switzerland and the European Union (EU) on updating the MRA are still ongoing. However, full ratification of the new agreement is expected to take time, potentially extending until 2027, as it may be subject to a Swiss referendum.

This renewed MRA will be a pivotal moment for Swiss medtech. It promises to ease regulatory burdens by reducing duplication of compliance processes, restoring easier access to the EU market, and lowering operational costs for manufacturers. Although the timeline is long, the industry is optimistic about the potential for smoother market integration.

In parallel, Switzerland is taking bold steps to broaden its regulatory landscape by working toward accepting FDA-approved devices. This is a strategic move to diversify market access and reduce reliance on the EU regulatory framework. In November 2022, the Swiss Parliament passed Motion 20.3211 (Motion Miller), which laid the groundwork for the potential recognition of FDA-approved devices.

While FDA-approved devices are not yet permitted in Switzerland, a regulatory framework is under development. It is expected that the Federal Office of Public Health will submit a discussion paper in Q2 2025, signaling the start of a multiyear process to establish new regulations. Depending on whether existing laws, such as the Therapeutic Products Act, require amendments, the process could take between one and six years to complete.

To support these initiatives, Switzerland is also investing in its regulatory infrastructure. The Swiss Le Mans database — managed by Swissmedic — is being developed to streamline the registration and post-market surveillance of medical devices. This database will help improve transparency, simplify compliance processes, and enhance regulatory oversight. The database will be launched in two phases, with initial modules set to go live in 2025 and full functionality expected by 2026.

Strategic Steps For Success In The Swiss Market

• Monitor developments in the Swiss-EU MRA negotiations to anticipate regulatory alignment by the end of 2025.
• Track the progress of FDA approval discussions, especially for companies with existing FDA-approved devices.
• Prepare for Swiss Le Mans database registration in 2025 to avoid delays in market access.
• Strengthen relationships with Swiss reps, as they will be pivotal in ensuring regulatory compliance and market access.
• Evaluate product portfolios to determine which devices may benefit from the upcoming FDA approval pathway.

The U.K.’s Post-Brexit Regulatory Framework: Building For The Future

Since leaving the European Union, the U.K. has been developing an independent regulatory system for medical devices, moving away from the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This shift has required new regulatory policies, oversight mechanisms, and compliance pathways to ensure patient safety while fostering innovation in the U.K.’s medical technology sector.

The U.K.’s new system focuses on three major pillars: the introduction of UKCA marking, the requirement for U.K. Responsible Persons (UKRP), and the development of a post-market surveillance (PMS) framework. In addition, the government is investing in artificial intelligence (AI) and digital health innovations, positioning the U.K. as a leader in regulatory science and emerging technologies.

UKCA Marking: Replacing CE Marking For Market Access

One of the most significant regulatory changes post-Brexit is the introduction of the UKCA (U.K. Conformity Assessed) marking, which replaces the EU’s CE marking for medical devices placed on the British market.

• UKCA marking is mandatory for all new devices entering the U.K. market: Manufacturers seeking to place medical devices on the market in England, Scotland, and Wales must now obtain UKCA certification through a U.K.-approved body.
• Transitional provisions allow CE-marked devices until 2030: While the U.K. initially planned for a shorter transition period, an extension was granted to ease the regulatory burden on businesses, particularly SMEs. This means that manufacturers that already have EU MDR/IVDR-approved devices can continue using CE marking for now, but those introducing new products must comply with UKCA regulations.
• Limited U.K. approved bodies: Unlike the EU, which has over 30 notified bodies for CE marking, the U.K. currently has only nine UK-approved bodies authorized to issue UKCA certifications. This has led to concerns about approval backlogs and delays, prompting companies to start the transition process as early as possible.

While UKCA marking is structurally similar to CE marking, there are key differences in conformity assessment requirements, necessitating a thorough review of regulatory strategies for companies operating in both the U.K. and EU.

The U.K. Responsible Person Model: Ensuring Local Compliance

To ensure regulatory oversight in the post-Brexit landscape, the U.K. introduced the U.K. Responsible Person (UKRP) model, a critical requirement for non-U.K. manufacturers looking to access the British market.

• Foreign manufacturers must appoint a UKRP to act as their official representative. The UKRP takes on regulatory responsibilities, including ensuring compliance with UKCA marking, documentation review, and post-market surveillance obligations.
• The UKRP serves as the primary point of contact with the Medicines and Healthcare products Regulatory Agency (MHRA). They are responsible for maintaining technical documentation, registering devices, and facilitating product recalls or safety investigations when necessary.
• Legal liability and obligations have been strengthened for UKRPs. Unlike the EU’s Authorized Representative (AR), UKRPs have direct legal accountability for regulatory noncompliance. As a result, manufacturers must choose reliable and experienced UKRPs who fully understand the evolving U.K. regulatory framework.
• Registration timelines and fees apply. Manufacturers must register their products with the MHRA, with a registration fee of £240 per Global Medical Device Nomenclature (GMDN) code. Additional annual fees are expected to be introduced, and a consultation on fee caps will take place in April 2025, with final regulations expected by May 2025.

With the UKRP model firmly in place, non-U.K. companies must proactively establish relationships with UKRPs to avoid delays and ensure seamless market entry.

New Post-Market Surveillance System: Strengthening Safety Oversight

To align with international best practices and improve patient safety, the U.K. is introducing a new post-market surveillance (PMS) framework that will be fully enforced starting June 16, 2025. This system aims to proactively monitor medical devices on the market, ensuring early detection of potential risks and regulatory noncompliance.

• Companies will be required to actively monitor device safety through real-world data collection, performance tracking, and periodic safety reporting.
• Incident reporting obligations will become more stringent. If safety concerns arise, manufacturers must submit reports promptly to the MHRA, detailing potential risks, adverse events, and corrective actions taken.
• The role of the UKRP in PMS compliance is critical. The UKRP is responsible for ensuring that manufacturers meet PMS obligations, including record-keeping and coordinating post-market investigations.
• Cost recovery and regulatory fees may increase. The U.K. government has emphasized a cost-recovery model, meaning PMS-related compliance fees could rise, requiring manufacturers to factor in higher operational costs when planning U.K. market entry.

Given the stricter post-market surveillance requirements, manufacturers should review and update their PMS strategies now, ensuring their systems are robust enough to comply with the new framework.

AI And Digital Health: The U.K.’s Innovation-First Approach

Beyond traditional medical device regulations, the U.K. is taking a forward-looking approach by actively fostering AI and digital health innovations. With the goal of becoming a global leader in AI-driven healthcare, the U.K. is investing in regulatory sandboxes and Centers of Excellence for Regulatory Science and Innovation.

• The AI Regulatory Sandbox is being developed to support early-stage medtech companies. This initiative allows companies to test and refine AI-driven medical devices in a controlled regulatory environment, helping them comply with U.K. standards before full market launch.
• Digital mental health technologies are a major area of investment. The U.K. government is focusing on improving regulatory pathways for digital therapeutics and AI-powered diagnostics, particularly in the field of mental health.
• Centers of Excellence for Regulatory Science and Innovation are being established to provide guidance and research support to companies developing AI and digital health solutions. These centers aim to ensure high regulatory standards while fostering innovation.
• AI-driven post-market surveillance is under consideration. The MHRA is exploring the use of AI for automated safety monitoring, potentially enhancing early risk detection and reducing regulatory bottlenecks.

The U.K.’s regulatory focus on AI and digital health presents significant opportunities for medtech companies developing cutting-edge medical technologies. Engaging with these initiatives early could provide a competitive advantage in the evolving U.K. market.

Strategic Steps For Success In The U.K. Market

As the U.K. moves forward with its post-Brexit regulatory framework, medtech companies must adopt a proactive strategy to maintain and expand their market presence. Some important considerations include:

• Begin the transition to UKCA marking now to ensure compliance before the 2030 deadline for CE-marked devices.
• Establish strong partnerships with UKRPs to navigate evolving regulatory obligations and post-market surveillance requirements.
• Develop comprehensive PMS strategies that align with the U.K.’s new surveillance framework to avoid penalties and ensure patient safety.
• Monitor upcoming changes in U.K. registration fees and budget accordingly for potential cost increases.
• Engage with AI regulatory sandbox initiatives if developing AI-powered medical devices, leveraging government support for innovation.
• Leverage the centers of excellence for guidance on digital health regulatory best practices, ensuring alignment with future AI regulations.

Conclusion

Both Switzerland and the U.K. are moving toward independent regulatory frameworks. This reality means companies must develop dual compliance strategies if they intend to operate across Europe and the U.K. The complexity is compounded by the need to engage with multiple regulatory bodies, invest in local partnerships, and establish clear processes for surveillance and compliance. Here are some important aspects to consider:

• Establish strong partnerships with Swiss reps and UKRPs to ensure continuous compliance.
• Invest in regulatory intelligence to stay ahead of upcoming changes in both markets.
• Evaluate product portfolios and map out pathways for EU, Swiss, U.K., and FDA approvals.
• Leverage digital tools and databases to streamline product registration and market surveillance.
• Engage with regulatory innovation initiatives, such as AI sandboxes and centers of excellence, to shape product development strategies.

Companies that act now by aligning with emerging frameworks, strengthening partnerships with regulatory representatives, and building agile, forward-looking strategies will be best positioned to navigate uncertainty and capitalize on new opportunities.

In a fast-moving, innovation-driven industry, regulatory readiness isn’t just a box to check, it’s a competitive advantage.

About The Author:

Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.