ISO 13485 is the quality management system that maintains the quality of medical devices in India. So, if you are dealing with medical devices, you must understand post-market surveillance in ISO 13485.

Post-market surveillance in ISO 13485 explains itself by its name. PMS is a requirement that helps in monitoring medical devices after they have been sold or used by the people in the market.

It is necessary to check the compliance of the medical devices 21 CFR Part 820 and the requirements of ISO 13485. The medical device industry must be indulged in post-market surveillance activity to ensure the safety and effectiveness of the medical device.

So, if you are in the medical device industry, you must dive deep and understand the meaning of post-market surveillance in ISO 13485.

What Is Post-Market Surveillance In The MDR?

Post-market surveillance, MDR, is assembling and checking the experience earned by the devices in the market. This surveillance is necessary as few risks can appear only after use. 

What Are The Post-Market Surveillance Requirements In The MDR?

The post-market surveillance requirement in the MDR is that manufacturers have to arrange all the technical papers to illustrate that the device was made and manufactured according to the applicable medical device regulations (MDR) needs.

What is the Purpose of Post-Market Surveillance?

The primary purpose of post-market surveillance, in short, PMS, is to promptly check the dangers it imposes. Also, it helps to check if there are more opportunities to improve the product:-

1. Checks the safety of medical devices
2. Adhere to required regulatory compliance
3. Provide lifecycle management

These are the purposes of post-market surveillance. Now that you understand the importance of post-market surveillance, let’s learn more.   

Who is Responsible for Post-Market Surveillance in ISO 13485?

Under Article 15, all manufacturers should assign a person responsible for regulatory compliance (PRRC) and check if the post-market surveillance (PMS) is adequately implemented. ISO/TR 20416:2020 needs top management to explain to the PMS team, comprising key department heads, to check the information. Last, top management assigns the PRRC and PMS team, and the PRRC arranges post-market surveillance activities.

What is the Post-Market Surveillance Strategy?

The post-market surveillance strategy is the plan to check the safety and effectiveness of the product, such as a drug or medical device, whenever it has been delivered to the market. The post-market surveillance includes information collection from all the users and data analysis.

What is the Importance of Post-Market Surveillance?

The post-market surveillance is crucial because it enables ongoing monitoring of the product’s safety and effectiveness after it comes into the market. This allows the identification of the possible risk not detected in the pre-market testing. 

Does ISO 13485 Require Post-Market Surveillance?

Yes, ISO 13485 does need post-market surveillance because manufacturers should have the existing arrangement to check the safety and efficiency of the medical product. This also acts as an integral part of the quality management system for medical devices. 

How do you Conduct Post-Market Surveillance in ISO 13485?

To conduct the post-market surveillance in ISO 13485, you should follow the pints as mentioned below:-

1. Make a post-market surveillance PMS plan according to the requirements of Article 84 and Annex 111 of EU-MDR
2. Perform the post-market surveillance PMS plan
3. Evaluate the gathered information, use effectual and correct methods and processes
4. Reference to techniques to accomplish the manufacturer’s obligations for post-market surveillance (PMS)
5. Make PMCF plan as per Annex XIV, or justify if PMCF is not applicable

Documents Required for Post-Market Surveillance in ISO 13485

In ISO 13485, these subsequent documents are required for post-market surveillance (PMS)

• Post-Market Surveillance Plan
• PMS Procedure
• Risk Management File
• Regulatory Reporting Records
• Information Collection and Analysis Records
• Periodic Reviews and Reports
• Complaint Handling Records
• Corrective and Preventive Action (CAPA)

Key Components of Post-Market Surveillance in ISO 13485  

Post-market surveillance PMS guarantees that all the instruments are safe. ISO 13485 represents the activities for monitoring and developing medical devices post-distribution. Check the table given below for key components of post-market surveillance:-

S.No	Main Components of Post-Market Surveillance as per ISO 13485	Description
1.	Complaint Handling & Reporting	All the manufacturers of medical devices compulsorily set up documented processes for getting, documenting, and checking complaints associated with their items. There are many sources you will receive complaints from, including customers, distributors, and regulatory agencies. Thoroughly examine the complaints if you are a manufacturer. Check for the main reason for the problem, and solve it with the right action if required. It is very important to report all the complaints as per regulatory needs.
2.	Adverse Event Monitoring & Reporting	Always monitor for adverse events, in simple words side effects of medical devices and unfavourable events such as deaths, serious illnesses, and injuries. All the adverse events should be mentioned in reports and provided to the regulatory authorities. Keep an eye out if any kind of adverse event happens, if it does every manufacturer should lead an investigation to check the associated risk.
3.	Trend Analysis & Signal Detection	It includes systematically reviewing and examining the post-market surveillance data to check the patterns, anomalies or trends that point out the likely safety or performance problems.The second important thing is signal detection regarding identifying signals of risks from medical devices based on surveillance data
4.	Corrective & Preventive Actions (CAPA)	The main goal of post-market surveillance is to address identified issues and obstruct the repetition. Every manufacturer should start suitable CAPA exercises when issues are recognized through complaints handling adverse event supervision and predictive analysis. It includes implementing design changes, updating labelling, and providing further training.

Integration of Vigilance Activities within ISO 13485

Check the pointers to understand the integration of vigilance activities within ISO 13485:-

Vigilance in Medical Device Regulations 

Vigilance related to medical device regulations points to the systematic process of reporting, monitoring, and assessing negative events or circumstances related to medical devices. It comprehends the timely diagnosis, investigation, and communication of every imaginable risk corresponding to medical devices to regulatory authorities, healthcare professionals, manufacturers and patients.

ISO 13485 Vigilance Activities Requirements

• ISO 13485 needs medical device manufacturers to obey applicable law requirements, including vigilance. This means discovering procedures for vigilance activities including similar regulations, for example, European medical device regulation (MDR), or the US Food and Drug Administration (FDA) needs.
• Vigilance activities are required to be integrated into the QMS “Quality Management System” described in the section of ISO 13485. This comprises an alignment surveillance process with another process of QMS. 
• It’s necessary to file vigilance activities for all manufacturers that assess, receive, and report unimaginable incidents.

Vigilance Reporting Responsibilities of Manufacturers

• Manufacturers are required to manage investigations to check the root cause of the  issue
• Use vigilance information to audit opportunities for product improvement and threat alleviation. This includes performing corrective and preventive proceedings to address recurring issues, providing training, or enhancing product design.

Conclusion

In conclusion, post-market surveillance (PMS) in ISO 13485 ensures that medical devices remain safe and effective after patients use them. The aim is to make important improvements, prevent problems, and guarantee that the devices comply with all regulatory requirements. PMS helps manufacturers enhance their products, ensure patients’ safety, and comply with all legal requirements.

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