Clinical trials don’t end once a product reaches the market. In fact, some of the most important insights come after a drug or device is approved. Post-market studies provide crucial data about long-term safety, performance, and patient outcomes in real-world settings.

This continuous monitoring is particularly essential for medical devices, where performance can vary across user environments and patient types. Companies that invest in thorough post-market strategies are better positioned to sustain market access, comply with evolving regulations, and safeguard patient wellbeing.

Why post-market studies are critical to patient safety

While pre-market trials are controlled and selective, post-market studies expose a product to broader, more diverse populations. This often reveals issues that weren’t visible during development, such as rare side effects or usability concerns.

These studies help regulators, healthcare providers, and manufacturers make informed decisions about labeling updates, risk minimization strategies, or even product recalls when necessary.

Common Objectives of Post-Market Clinical Studies

• Monitor safety and performance in real-world use
• Evaluate long-term effectiveness and durability
• Identify risks in subpopulations not covered in pivotal trials
• Support regulatory filings for expanded indications
• Inform physician guidelines and reimbursement policies
• Compare new devices with existing alternatives
• Collect patient-reported outcomes and quality of life metrics
• Track use-patterns and compliance over time

Tools and strategies for medical device manufacturers

For manufacturers of medical technologies, post-market efforts aren’t just good science — they’re a regulatory requirement. With the EU MDR and IVDR frameworks now in full effect, companies must build proactive surveillance plans into their lifecycle strategies.

A post market surveillance study is one of the key tools that manufacturers use to fulfill their obligations under these regulations. These studies gather evidence from actual use, feeding into technical documentation, safety reporting, and future regulatory submissions.

Equally important are medical device CER services, which support the development of Clinical Evaluation Reports based on both pre-market and post-market data. These reports are required to demonstrate continued benefit-risk balance and compliance with GSPR (General Safety and Performance Requirements).

Key Post-Market Services for Device Companies

• Study design tailored to MDR/IVDR expectations
• Registry management and observational study coordination
• Data collection platforms that ensure traceability
• Real-time monitoring and signal detection
• Compilation of Clinical Evaluation Reports (CERs)
• Integration of PMS results into regulatory submissions
• Ongoing literature surveillance and analysis
• Advisory on Notified Body interactions and audits

In an increasingly regulated and data-driven world, post-market clinical research is no longer optional. It’s the foundation for responsible innovation, patient trust, and sustained product success.