Building Global-Ready PMS Systems for MDR, FDA, TGA, and Health Canada

Why Post-Market Surveillance Now Starts Before Launch

In today’s regulatory landscape, agencies such as the EMA, FDA, Health Canada, and TGA have significantly raised expectations for post-market surveillance (PMS). What was once considered a post-launch requirement is now recognised as a responsibility that begins early in the product lifecycle. For instance, EU MDR’s Article 61 and Annex XIV explicitly require the planning of post-market clinical follow-up (PMCF) activities prior to market launch.

This shift underscores the need for manufacturers to integrate PMS into their broader clinical and regulatory strategies from the start, using data to inform real-world decisions on safety, performance, and residual risk.

How MedTech Companies can Design PMS Systems with Strong Clinical Planning

Building an effective PMS system starts with clinical planning. This includes defining which clinical data are needed, how they will be collected, and how that data will support regulatory submissions across jurisdictions. Cross-functional collaboration between regulatory affairs, vigilance, medical writing, and R&D ensures that PMS planning is both compliant and actionable

A Use Case: Aligning PMS Around Real-World Product Use 

Consider a hypothetical example of a MedTech company developing femoral hip implants. Though stems and heads are often evaluated independently during regulatory submissions, they are used together in clinical practice. This creates a challenge in post-market traceability.

To address this, the company could implement an internal PMS dashboard to track component combinations implanted in real patients. They might integrate data from PMCF activities, including literature reviews, clinical studies, and national joint registries, and supplement this with vigilance reports and preclinical testing.

This integrated view allows better alignment across CERs, SSCPs, and PSURs, and helps ensure that benefit-risk conclusions reflect real-world use. 

The Value of Meaningful Clinical Data Across Regions

When PMS systems are designed to serve both regulatory and clinical objectives, the resulting data can support better outcomes and smoother compliance across regions. In the US, FDA’s increased reliance on real-world evidence (RWE), and the focus on vigilance and reassessment by TGA and Health Canada, support the value of using real-world data for post-market decision-making.

Although regional requirements vary, convergence trends are evident. EU MDR requires ongoing evaluation and PMCF; FDA enforces post-approval studies and 522 orders; and TGA and Health Canada implement periodic reassessments and vigilance reviews. The Medical Device Single Audit Program (MDSAP) also fosters harmonised practices across these markets

How to Design Scalable, Compliant PMS for Global Markets

Based on experience with joint implants, here are five practical strategies MedTech companies can follow to develop scalable, compliant PMS systems:

1. Start early: Link PMS planning to design inputs and risk documentation.
2. Tailor PMCF: Adjust activities based on device classification and known uncertainties.
3. Use standardised templates: Align CERs, PSURs, and SSCPs with global structures to ensure consistency.
4. Integrate diverse data sources: Use PMCF data from literature, registries, and clinical studies, supported by vigilance and preclinical evidence.
5. Ensure alignment across documents: Conduct systematic cross-checks between CERs, PSURs, and SSCPs to maintain coherence and traceability.

These steps support the creation of PMS frameworks that are adaptable, sustainable, and acceptable across key markets.

References

• European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Official Journal of the European Union. 2017.
• MDCG. Guidance on clinical evaluation (MDCG 2020-13). Medical Device Coordination Group; 2020.
• U.S. Food and Drug Administration. Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. Guidance for Industry and FDA Staff; 2016.
• RAPS. The Regulatory Professional’s Role in Clinical Strategy. Regulatory Focus; 2021.
• TGA. Australian Regulatory Guidelines for Medical Devices (ARGMD). Therapeutic Goods Administration; 2021.
• Health Canada. Guidance Document for Mandatory Problem Reporting for Medical Devices. 2022.
• MDCG. PMCF Plan and PMCF Evaluation Report Templates (MDCG 2020-7 & 2020-8). 2020.
• U.S. FDA. “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” Guidance Document; 2017.
• IMDRF. Post-Market Clinical Follow-up Study Report – IMDRF/MCWG/N65FINAL:2019.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.