Drugdu.com expert's response:

 

Many IVD enterprises, when preparing for EU market compliance, tend to prioritize pre-market requirements such as CE certification, technical documentation and performance evaluation.
However, regulatory obligations do not terminate once the product is placed on the market.

In accordance with the EU IVDR, manufacturers are mandated to establish a Post-Market Surveillance (PMS) system to continuously collect post-launch real-world usage data, safety performance and potential risks of the device, and implement corresponding corrective actions based on the feedback.

For IVD enterprises planning to access the EU market, the post-market surveillance plan shall be established as follows:

1. Define the objectives and scope of post-market surveillance in advance

Prior to developing the PMS plan, the enterprise shall explicitly determine:

The product portfolio covered by the surveillance scope;

The sales territories of the products;

Target user groups;

Risk class of each product;

Key issues requiring prioritized attention.

Different IVD products have distinct surveillance priorities.

For example:

Testing reagents shall focus on testing accuracy, false positive/negative incidents and batch stability;

Instruments and equipment shall lay more emphasis on performance drift, software anomalies, malfunctions and end-user feedback.

Thus, enterprises shall formulate targeted surveillance schemes aligned with product characteristics.

2. Establish data collection channels

The core of post-market surveillance lies in continuous acquisition of market feedback.

Enterprises shall pre-plan data sources, including:

Customer complaints;

Distributor feedback;

After-sales service records;

Product return or replacement records;

On-site usage feedback;

Published literature and industry intelligence;

Information released by competent regulatory authorities.

Many enterprises only focus on received complaints after product launch, while PMS is far beyond mere issue handling.

Even in the absence of severe complaints, regular collection and analysis of market information are required to confirm that the product consistently meets the intended performance.

3. Formulate complaint and incident handling procedures

Under the IVDR regulatory framework, complaint management is a critical component of post-market surveillance.

Enterprises shall clearly define:

The definition of a complaint;

Issues that trigger mandatory investigation;

Personnel responsible for assessment;

Standards for documenting the entire handling process;

Timelines for reporting to the competent authority.

For instance, when users report abnormal test results of a specific product batch, the enterprise shall assess:

Whether the incident is attributed to product quality defects;

Whether other batches are affected;

Whether corrective and preventive actions are required;

Whether relevant authorities or customers need to be notified.

Complete records and standardized handling procedures facilitate subsequent risk assessment for enterprises.

4. Integrate with the risk management system

Post-market surveillance does not operate as an independent process.

Enterprises shall correlate market feedback with risk management documentation.

For example:

Frequent user operational errors identified after product launch;

High failure rate of a specific component;

Deviation of a performance indicator in real clinical use.

All such information may alter the outcomes of risk analysis.

Based on newly obtained market data, enterprises shall evaluate whether updates are required for:

Risk management reports;

Instructions for use (IFU);

Performance evaluation documentation;

Technical documentation;

Labels and usage requirements.

5. Establish PMS reporting and periodic evaluation mechanisms

Enterprises shall define surveillance frequencies based on product categories and risk classes.

Surveillance content generally includes:

Number of complaints collected;

Adverse event statistics;

Customer feedback analysis;

Market trend variations;

Status of corrective and preventive actions (CAPA).

For higher-risk products, enterprises shall also prepare Periodic Safety Update Reports (PSUR) in compliance with regulatory requirements.

The report shall cover:

Post-market performance of the product;

Variations in identified risks;

Measures that have been implemented;

Necessity for further improvements.

6. Define responsible personnel and internal workflows

A common issue for many enterprises is the lack of clear responsibility allocation rather than insufficient documentation.

Post-market surveillance typically involves multiple departments:

The regulatory department is responsible for ensuring regulatory compliance;

The quality department is in charge of complaint management and CAPA implementation;

The R&D department undertakes technical assessment;

The sales and after-sales departments are responsible for collecting market feedback.

Enterprises shall explicitly specify:

Personnel responsible for information collection;

Personnel responsible for risk analysis;

Personnel authorized to approve corrective measures;

Personnel in charge of documentation maintenance.

This enables rapid response when incidents occur.

7. Establish an information communication mechanism for overseas partners in advance

For IVD enterprises that sell products via authorized representatives and importers, special attention shall be paid to the timely feedback of overseas market information.

Enterprises shall agree in advance on:

The frequency of market status updates from authorized representatives;

The submission protocol for complaints;

The notification procedure for serious incidents;

Documents that need to be archived.

A large amount of market information will not be directly transmitted to the manufacturer. An imperfect communication mechanism with overseas partners may lead to the enterprise failing to identify risks in a timely manner.

Conclusion

Under the IVDR, post-market surveillance is not merely post-launch complaint handling, but a complete management process covering continuous information collection, risk assessment and product improvement.

For IVD enterprises, the completion of CE certification does not mark the end of compliance work. A well-established PMS plan helps enterprises identify market issues at an earlier stage, and provides support for subsequent product optimization, registration maintenance and overseas business expansion.

By building up the post-market surveillance system before entering the EU market, enterprises will gain greater initiative when responding to future market changes.

By editor