Launching a light therapy device is not the end of the regulatory journey. In fact, once a product enters the market, a new and equally important phase begins: post-market surveillance (PMS).

Post-market surveillance ensures that a device continues to perform safely and effectively under real-world conditions. For light therapy devices, which are often used repeatedly and over long periods, PMS plays a critical role in maintaining regulatory compliance, product quality and market trust.

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What Post-Market Surveillance Means in Practice

Post-market surveillance refers to the systematic collection and evaluation of data after a device has been placed on the market. Its purpose is to identify potential risks, performance issues, or opportunities for improvement throughout the product’s lifecycle.

Typical PMS activities include:

• monitoring user feedback and complaints
• tracking adverse events and incidents
• reviewing clinical and performance data
• implementing corrective or preventive actions when needed

Rather than being a one-time obligation, PMS is an ongoing process that supports long-term device safety and reliability.

For devices requiring ongoing clinical evidence, this may include Post-Market Clinical Follow-up (PMCF) studies that systematically collect clinical data to confirm long-term safety and performance.

Regulatory Expectations Under MDR and FDA

Both European and U.S. regulators place increasing emphasis on post-market responsibility.

Under the European Medical Device Regulation (MDR), manufacturers must implement a formal PMS system, supported by:

• a post-market surveillance plan
• periodic safety update reports (PSURs) for Class III and implantable devices
• ongoing clinical evaluation and trend reporting

In the United States, the FDA requires post-market monitoring through:

• adverse event reporting under 21 CFR Part 803
• complaint handling systems
• corrective and preventive action (CAPA) processes

While the structures differ, both frameworks expect manufacturers to actively monitor device performance and respond promptly to any emerging risks.

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Why PMS Is Especially Important for Light Therapy

Light therapy devices are often used frequently, sometimes daily, and across a wide range of users and environments. This makes real-world data particularly valuable.

Effective PMS helps manufacturers:

• identify rare or long-term effects not seen during testing
• refine treatment protocols and user instructions
• improve device durability and usability
• protect brand reputation by addressing issues early

For devices positioned in wellness, medical, or professional markets, PMS is a key factor in maintaining regulatory approval and commercial credibility.

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From Compliance to Competitive Advantage

While post-market surveillance is a regulatory requirement, forward-thinking brands treat it as a strategic tool. As the light therapy market matures, regulators are placing greater emphasis on lifecycle responsibility rather than one-time approval. Devices must remain safe and effective not only at launch, but throughout years of real-world use.

Brands that actively analyze post-market data gain insights that support:

• product improvements and future device generations
• rapid response to regulatory inquiries
• market differentiation through documented real-world performance
• expansion into new markets with credible safety data
• long-term trust with users, distributors, and clinical partners

At Light Tree Ventures, post-market surveillance is treated as an integral part of product development. Devices are designed and manufactured within ISO 13485-certified quality systems, with built-in processes for complaint handling, traceability, and continuous improvement that align with both MDR and FDA requirements.

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Final Thoughts

Post-market surveillance is not an administrative burden; it is a core element of responsible medical device manufacturing. For light therapy devices, effective PMS protects users, supports compliance, and strengthens product credibility over time.

Brands that invest in post-market systems early are better prepared to adapt, scale, and succeed in regulated markets.

Because in light therapy, long-term success depends not only on innovation, but on continuous responsibility after launch.

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References

• ISO – ISO 13485:2016 — Post-Market Activities
  https://www.iso.org/standard/59752.html

• MEDDEV 2.12/1 rev. 8 – Guidelines on a Medical Devices Vigilance System
  European Commission
  https://ec.europa.eu/docsroom/documents/17522
• Sorenson, C. et al. (2023). Post-Market Surveillance Systems for Medical Devices in the EU: Challenges and Best Practices.
  Health Policy, Elsevier
  https://doi.org/10.1016/j.healthpol.2023.104814
• International Medical Device Regulators Forum (IMDRF) – Principles of Medical Device Vigilance and Market Surveillance
  https://www.imdrf.org/documents/principles-medical-device-vigilance-and-market-surveillance

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