The challenges of post-marketing surveillance (PMS) are increasing. Keeping up with complex and evolving regulatory requirements, such as those mandated under EU MDR 2017/745 or FDA 21 CFR Part 822, requires constant vigilance. You need to be able to find clarity in the data quickly, identify emerging risks early, and act swiftly. 

Eurofins Medical Device Consulting offers a comprehensive and compliant PMS service designed to reduce your regulatory burden and enhance patient safety.

Our expert teams work globally to support manufacturers with both reactive and proactive post-market surveillance that aligns with current expectations from regulators in each region. The fully compliant PMS systems we help our clients to implement include:

• Reactive PMS: Analysis of real-world data, including user feedback and clinical studies
• Proactive PMS: Post-Market Clinical Follow-up (PMCF), actively collecting clinical data to assess long-term device safety and performance

Using validated processes, our scientists collate and assess information from a broad range of data sources, including user and clinician feedback, clinical investigations, scientific literature, and market and vigilance reports. We can support every step, through from initial planning to reporting:

• PMS Plan: Clear methodology for collecting and evaluating data
• PMS Report: Regular updates highlighting findings and trends
• PSUR (Periodic Safety Update Report): Comprehensive evaluations submitted in accordance with timelines and scope defined by the applicable regulations

With proven experience in data integration and risk evaluation, we identify potential issues early, supporting your teams in the design and implementation of corrective and preventive actions (CAPA) that satisfy regulator expectations and protect public health.

Eurofins Medical Device Consulting ensures access to specialised expertise and local regulatory insight, helping you stay compliant across markets without duplicating effort. Whether you're launching a Class I device or maintaining a Class III implant on the market, we will bring clarity, consistency, and confidence to your PMS programme.