TOSOH: Defining a Postmarket Surveillance Strategy to Drive Risk-Based Decisions

Postmarket surveillance (PMS) is not just a compliance exercise — it’s a strategic function that drives product safety, supports business growth, and informs smarter decision-making. As medtech companies face increasing regulatory demands and data complexities, PMS is increasingly valued for insights provided into operations and strategy.

By integrating advanced technologies like artificial intelligence (AI), building cross-functional teams, and improving data quality, manufacturers can streamline compliance, strengthen risk management, and uncover insights that enhance both product performance and patient safety.

“Postmarket surveillance is far more than just a regulatory requirement,” says Emiliano D’Urso, PMS and regulatory intelligence manager at TOSOH and chair of the IVD PMSV Working Group for MedTech Europe. “Done well, PMS can unlock insights that strengthen your technical documentation, improve product safety, and even enhance your competitive position.”

A Critical Regulatory Focus

Postmarket surveillance is a focal point in the medical device lifecycle, with regulatory bodies worldwide — including the EU and U.S. — demanding higher standards for postmarket monitoring.

The introduction of the European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) significantly increased the number of requirements in PMS. Additionally, the upcoming UK PMS framework and evolving legislation like the EU Product Liability Directive are further raising manufacturer expectations.

These changes require companies to adopt stronger postmarket surveillance strategies that prioritize device safety throughout the product lifecycle and improve documentation quality. Additionally, companies must adapt their processes for all regions where the device is placed, such as the EU and UK.

Barriers to Improvement

As PMS gains a more prominent role, medtech manufacturers face several key challenges that demand strategic solutions.

  1. Data collection and real-world evidence – Collecting accurate, high-quality data remains a major PMS challenge. Traditional methods can fall short, producing inconsistent data that delays complaint investigations and hinders effective vigilance assessments. Manufacturers should focus on capturing more relevant and complete information to improve outcomes and enable better informed risk assessments.
  2. Risk and documentation alignment – Medtech manufacturers face increasing pressure to maintain consistent risk management processes and documentation. Regulatory bodies expect postmarket data to align closely with risk files, creating a clear link between safety data, technical documentation, and clinical evaluations. Achieving this cohesive narrative is essential for meeting regulatory expectations and streamlining notified body reviews.
  3. Navigating global regulatory differences – The complexity of global PMS requirements presents a significant challenge, particularly for IVD manufacturers now facing more oversight under the IVDR classification. Cross-functional postmarket teams are proving effective in managing these complexities by bringing together quality, regulatory, production, and support teams to address regional requirements, jointly conduct impact assessments, and ensure data alignment across markets.

Strengthening Documentation and Reporting

For many medtech companies, Periodic Safety Update Reports (PSURs) are a new requirement that present both logistical and strategic challenges.

D’Urso advises treating the PSUR as a standalone document that tells a clear and concise safety story. To improve clarity and avoid delays, manufacturers should begin with an executive summary that highlights key insights and conclusions. Though not mandatory, following the MDCG 2022-21 template should help expedite reviews by providing a standardized structure for regulators. Changes to device grouping or data collection periods should always be justified. Meanwhile, automation can reduce manual effort in compiling and updating PSURs, while simultaneously improving accuracy.

Role of AI and Emerging Technologies

AI and machine learning have the potential to transform postmarket surveillance by streamlining data analysis, complaint handling, and signal detection. D’Urso outlined use cases for leveraging auto-categorization, chatbots for complaint intake, and predictive models for vigilance assessment that can help manufacturers prioritize issues and improve efficiency. Additionally, an automated system that enables the drafting of PSURs could then reduce manual transcription, lower costs, and enhance accuracy.

D’Urso also advises that while these technologies offer significant value, careful validation is crucial to ensure reliability and prevent errors. Without proper oversight, AI models risk introducing bias or inconsistencies that could undermine PMS efforts. Companies that integrate AI thoughtfully can unlock new insights, improve transparency through reporting, and reduce administrative burdens.

Looking Ahead: Building a Resilient Postmarket Strategy

To stay ahead in an ever-evolving regulatory landscape, medtech companies must adopt forward-looking postmarket surveillance strategies that balance the need for detailed oversight, technology, and global implementation.

With regulatory bodies implementing greater public access to vigilance data via EUDAMED, manufacturers must conduct a thorough gap assessment to ensure their reporting transparency aligns with evolving compliance expectations. As D’Urso states, “While increased public access to vigilance is crucial to building trust and improving the overall industry, it also requires companies to reassess how they manage transparency.”

Meanwhile, global frameworks like the UK PMS framework are adding complexity, making agility crucial for maintaining consistency across markets. Cross-functional teams and centralized systems will play a vital role in helping manufacturers manage these challenges and improve operational performance.

Postmarket surveillance is evolving into a powerful strategic function that extends beyond compliance. By improving data quality, embracing advanced technologies like AI, and enabling integrated PMS teams, medtech companies can reduce costs, improve documentation, and strengthen product safety.

“The future of PMS isn’t just about compliance — it’s about driving better business outcomes,” concludes D’Urso. “Companies that embrace forward-looking strategies and emerging technologies will gain a competitive edge in the evolving medtech landscape.”

For deeper insights into building a proactive postmarket quality strategy, navigating critical barriers, and implementing comprehensive solutions, download the 2025 Medtech Postmarket Quality Benchmark Report.