Post-Market Surveillance (PMS) is no longer just a checkbox, it’s a business-critical function that offers both regulatory security and commercial opportunity.
What is Post-Market Surveillance and why does It matter?
Post-Market Surveillance (PMS) is the ongoing process of collecting, analysing, and acting on data about a medical device once it’s been placed on the market. It’s an essential requirement under the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (EU IVDR 2017/746) – but it’s far more than just a legal obligation.
The main purpose of PMS is clear: to ensure patient safety. But when done well, it also safeguards your brand, fuels product innovation, and opens doors to international markets with aligned safety expectations.
PMS under EU MDR and EU IVDR: what’s changed?
While PMS isn’t new, the EU MDR and IVDR have significantly raised the bar, mandating a more structured, lifecycle-based approach to monitoring safety and performance. Manufacturers must now maintain ongoing oversight of:
• Device performance and safety trends
• Real-world usage scenarios
• Feedback from patients, providers, and supply chain partners
• Market-specific incidents or product complaints
Rather than reacting to problems, manufacturers must now proactively collect and evaluate data to identify emerging risks, trends, and opportunities.
The hidden value of PMS
Many manufacturers view PMS as a mere cost centre – but the truth is a robust PMS strategy can:
• Reduce risk: Early identification of design flaws or demographic-specific issues prevents costly recalls and patient harm.
• Improve products: Real-world insights support iterative improvements in design and usability.
• Enable market access: With other geographies (like the UK) adopting similar PMS requirements, efficient systems support faster compliance in multiple jurisdictions.
• Support innovation: Data collected can identify off-label use or new user groups, leading to expanded indications or new product lines.
Common misconceptions: PMS is just about paperwork
Yes, PMS can feel documentation-heavy, but it doesn’t have to be inefficient. Smart planning can align PMS with other reporting timelines like PMCF, PSUR, CER, or PER to minimize duplicated efforts. When PMS cycles are embedded in your quality system as a routine process, not a last-minute scramble, your entire operation becomes more agile and audit ready.
The role of AI in modern PMS
AI tools are beginning to support PMS activities, especially for literature reviews and signal detection. When implemented carefully, AI can streamline repetitive tasks and surface valuable trends, but human oversight remains essential, and regulatory bodies still expect Expert Reviewers to validate AI-assisted outputs.
Beyond Europe: PMS as a gateway to global markets
With upcoming PMS regulations in the UK and increasing scrutiny worldwide, a solid PMS system helps streamline entry into multiple markets. A centralized, well-mapped PMS framework allows you to:
• Reuse literature reviews across regions
• Consolidate data for cross-jurisdiction analysis
• Meet GDPR, HIPAA, and other data privacy laws
• Leverage dashboards and analytics for real-time monitoring
However, it’s important to note that local definitions matter, and a term like “incident” may mean one thing under EU law and something else under UK regulation. Failing to capture these nuances can cause compliance headaches and missed opportunities.
Laying the groundwork for future readiness
As new regulations like the UK PMS Statutory Instrument (expected in 2025) and the updated EU Product Liability Directive (effective in 2026) come into play, PMS will become even more critical. The burden of proof will increasingly shift to the manufacturer, making accurate and defensible documentation your first line of defence.
Your PMS system will need to show:
• How feedback is collected across all stakeholders (including supply chain)
• How risks are analysed and mitigated
• How your device performs in real-world use, including edge cases and misuse
• How you react to new safety information, even if it comes from a distant market
PMS isn’t just about compliance – it’s a strategic enabler. Medical device manufacturers who see PMS as a burden are missing the bigger picture. Those who invest in efficient, scalable, and data-driven PMS processes will not only meet regulatory expectations but outperform competitors in safety, innovation, and trust.
Read more in our newest whitepaper and don’t miss our next blog, that will explore how to build a streamlined PMS cycle that reduces duplication and sets you up for success in audits, product development, and market expansion.