In the previous articles, we have discussed taking an idea from the back of the napkin design to the commercialization stage. A successful medical device launch is certainly a moment of celebration for all the stakeholders. However, after the entry of the medical device into the market, your job is not over, you also need to ensure that your medical device continues to be safe and effective. This process of ensuring the safety of the device after its launch is commonly referred to as medical post-market surveillance or PMS. This system provides continuous feedback on a medical device that is on the market to maintain the product’s quality and performance. As a medical device company, you have to do PMS not only because it is required by regulatory agencies in the United States and EU but by doing this exercise correctly, you can improve the quality of your medical device, provide better UX and user service, leverage the learnings for the version 2.0 of your device, and most importantly you can minimize the risk of adverse events even before their occurrence.
This article focuses on important points to remember while implementing the PMS system.
PMS is designed to curtail the exposure arising from the events through functional warnings and product recall processes. The goal of the article is also to simplify the regulatory jargon and obligations to help you understand the differences in the requirements between the US and the EU. Highlights of the article are:
- What is PMS
- How it differs from vigilance.
- PMS elements.
- Functionality of the PMS system.
- PMS and Risk management.
- Implementation of data collection for PMS and trend analysis
- Overall benefits of implementation of PMS system
- Report timelines
Table of Contents
What is Post-Market Surveillance?
European Medical Devices Directive, AIMDD, or IVDD did not formally define the PMS in the guidance document, but as per the Medical Device Regulations and In Vitro Diagnostic Regulations (IVDR), PMS is the process of ensuring that all activities carried out by medical device manufacturers to establish and maintain a systematic procedure to proactively collect and review experience gained from medical devices they launch in the market or put into service to identify any need to immediately apply any necessary corrective or preventive actions .
On the other hand, the PMS in the US is a very clear regulatory requirement by the FDA for 510(k) and PMA approval/submissions. The PMS allows the US FDA to require medical device manufacturers to perform studies of high-risk medical devices (depending upon the classification of your medical device) that received the 510(k) clearance or PMA approval. Recently, the FDA introduced an initiative that has overlapping objectives to PMS to collect and review data on medical devices. These are known as Total Product Life Cycle (TPLC) and Idea Development, Exploration, Assessment, and Long-term Study (IDEAL).
PMS can be broadly classified into two segments: Proactive Segment: In this category, the PMS can be performed proactively using customer surveys or post-market clinical follow-up (PMCF) (MEDDEV 2.12/2, rev 2) studies whereas in the Reactive Segment: the PMS activities (NB-MED 2.12 rec 1) are performed reactively such as vigilance (MEDDEV 2.12/1 rev 8), non-conforming material reports (NCMRs) or correction action requests (CARs).
|Proactive PMS actions||Reactive PMS actions|
| || |
Post-Market Surveillance vs Vigilance
In certain cases, the medical device companies use PMS and vigilance alternatively or in certain instances in an interchanging manner, however, if you take a look at the big-picture, the scope for both PMS and vigilance differs from each other, and vigilance is just one aspect of the reactive category of PMS. Vigilance addresses the incidents, field-safety corrective actions (FSCAs), or recalls, that can occur with medical devices or in-vitro diagnostic devices in cases when they fail to perform as per their intended use. This also includes the scenarios when the failure to perform as intended leads to the worst cases leading to injury or death of the end-user. It is mandated by regulatory bodies to take timely, coordinated actions and the manufacturer needs to have a provision of information concerning the incidents, field-safety corrective actions, or recalls that are related to the medical device. The sole purpose of the medical device vigilance is to provide protection for the health and safety of the end-user, mitigate the risk of potential incidents and prevent its recurrence. Vigilance can also evaluate the effectiveness of corrective actions and preventive actions (CAPAs), and monitor the CAPAs to learn from past experiences. On the other side, the PMS is a set of activities that including vigilance and other reactive actions but also includes proactive actions to mitigate the risks.
Medical Device Post-Market Surveillance: Functions
Once your medical device enters the market after successful launch/commercialization, the PMS system should allow you to collect, review, and assess all information about the device, and related competitors’ devices, once it is on the market. As per the Notified Bodies Medical Devices (NB-MED 2.12 rec 1 – PMS) outlined PMS as a system that can perform the following functions:
- Detect manufacturing problems,
- Improve medical device quality,
- Perform risk analysis verification;
- Can do long-term intelligence of performance, chronic complications, performance trends, and performance in different user populations;
- Detection of potential mechanisms the device may be misused;
- Provide feedback on indications for use, instructions for use, training required for users, Feedback on customer satisfaction and market performance and sustainability;
- Incident reports identification (including FACAs).
The PMS document can help the manufacturer to understand the performance of the device when it makes it to the market and it also creates a continuous feedback loop for the manufacturer to maintain high standards of product quality. In certain cases, PMS can forewarn the medical device companies about the incident occurrence, product recalls, and potential failures. When the medical device engineering and manufacturing teams work in tandem for the design transfer and PMS, they can find the best materials, share insights into geometries and critical steps that will help facilitate a smooth manufacturing process, and can discuss the general design for manufacturing suggestions. For regulatory purposes, the main goal of the design transfer activity is to finalize your device master record. In one sentence, if you can start to build design transfer early on in your design review process, the actual design transfer meeting will be a formality of approval for the design outputs.
We have discussed risk assessment before in the Medical device series but it is important to remember that the PMS implementation also begins with the effective risk assessment. Please refer to risk and hazard assessment with risk analysis and risk evaluation criteria as per ISO 14971 which was covered in the earlier articles. It is noteworthy to remember that any potential risk mitigation that is taken out of PMS needs to be re-evaluated to verify that risk mitigation has reduced the risk-hazard ratio, it is not leading to creating newer risks.
Elements a PMS must include
As per the Medical Device Directive (93/42/EEC), the PMS document should address and be inclusive of:
- Determination if any changes are required to the original medical device risk assessment document?
- A methodical and systematic process to verify and evaluate a product that is broad enough in scope and not just limited to customer complaints.
- Objective evidence should be included in the risk management file.
- Any new hazards should be evaluated and determine if there have been changes in the acceptability of risks as opposed to the original definition of risks.
- Any feedbacks and revisions of risk assessment/management should be included and revised.
As a medical device startup you need to remember that once your medical device has made to the market, anything about your medical device that may come up including literature reviews, PMCFs, customer complaints, and surveys becomes part of the PMS. The list of PMS also includes expert user groups, user reactions, responses generated during medical device training programs, any sort of media, trade shows, maintenance/ service reports for your medical device, field evaluation, trade-ins, in-house testing, and failure analysis. It is important to remember that I have neither included the exhaustive list of PMS data here and not all sources I have included here that may be considered appropriate for all the medical devices. So it is advisable to work with a consultant or an expert on PMS to obtain the list customized to your medical device.
Post-Market Surveillance: Data collection
How do you collect the data for the PMS? You have to do that in a way that you have all the procedures are in place to capture customer feedback. PMS data collection procedure consists of customer complaints and concerns related to your medical device, procedures to control non-conforming materials and products, CAPAs, PMS, servicing (if needed), or customer surveys. Good documentation is very important for PMS and you have to ensure all applicable departments and personnel in your organization who are directly or indirectly involved in the collection of data follow good documentation practice and ensure that all information is documented.
Under MDR following are the new requirements for the PMS:
|Post-market Surveillance||Article 83: Post-market surveillance system of the manufacturer|
|Risk Management||Annex I,3(e) Risk management system|
|Clinical evaluation plan and report||Annex XIV Clinical evaluation and post-market clinical follow-up|
|Post-market Surveillance plan and report||Annex III: Technical documentation on post-market surveillance |
Article 84: Post-market surveillance plan
Article 85: Post-market surveillance report (Class I)
|Vigilance||Article 87: Reporting of serious incidents and field safety corrective actions |
Article 88: Trend reporting
Article 89: Analysis of serious incidents and field safety corrective actions
Article 90: Analysis of vigilance data
|PMCF plan and evaluation report||Annex XIV Clinical evaluation and post-market clinical follow-up|
|Periodic Safety Update Report||Article 86: Periodic safety update report (Class IIa, IIb, III)|
|Summary of Safety and Clinical |
|Article 32: Summary of safety and clinical performance|
Once you have gathered the data the next action item is to review and analyze the collected information and perform the trend analysis. As you have realized by now that PMS is not a one-time exercise but data review and trend analysis are required periodically, if not quarterly at least annually. Both FDA and ISO 13485 require the medical device applicant to perform an annual PMS review as part of their formal management review meeting. However, in the case of medical device startups, I advise them to perform the PMS more frequently such as monthly or at least quarterly for the betterment of their product and to establish a truly effective program. The frequency of the PMS also depends on the quantity and type of feedbacks received for your medical device. One of the major determinants of vigilance reporting is the evaluation of complaints and feedbacks which can help to decide if further action is necessary. To properly implement the vigilant system you should involve the users and ask for their cooperation, also involve manufacturers, other competent authorities, and any relevant user groups that could effectively facilitate the vigilance system.
Benefits of Post-Market Surveillance
A properly implemented vigilance system can help to detect previously unidentified and unknown adverse product information. Any incidents or adverse events associated with the medical device which otherwise potentially lead to a serious deterioration in health or even death can be prevented from recurring by a properly implemented vigilance system. I have seen cases when the vigilant system became a source of information for unknown manufacturing problems.
Other benefits of a properly implemented vigilant system include the medical device design evaluation and assessment of the risk to clinical benefit ratio for your medical device. This will lead to decisions about whether the risks linked to your medical device are relatively lower than the clinical benefits it has to offer to the end-user. A vigilant system can also help in deciding if any corrective and preventive actions (CAPAs) are necessary to resolve the problems with your device, via product design or manufacturing changes, root cause resolutions, product labeling, and/or training to prevent future occurrence, etc. Additionally, the data gathered through the vigilant system can be channeled into documents such as the Risk Management File and Clinical Evaluation Report (CER). These new data from a vigilant system might help in identifying further risks that were not previously documented, as well as demonstrate if the risks are still within the acceptable range. The CER is used to assess and analyze clinical data about a medical device to verify the clinical safety and performance of the device.
Articles 85 and 86 highlight the new requirements of PMS under the MDR. The data gathered under the PMS can be used for the following purposes :
- Modify or revise the risk to benefit ratio determination process and modify risk management (if needed);
- Based on the PMS revise the design or manufacturing information or both. This may include any revision for the user instructions or labeling of the device;
- Revise the clinical evaluation and medical device performance evaluation;
- Update the summary of safety and clinical performance
- Need for CAPAs: Identification of the requirements for any corrective and preventive actions:
- Identification of various options for the improvement of medical device usability, performance, and/or safety of the medical device;
- Trend reporting
Medical Device Post-Market Surveillance: Summary of report timelines
|Class I||Class IIa||Class IIb||Class III||Implantable|
|PMSR||PSUR (Throughout the lifetime of the device)|
|As necessary||As necessary, |
but at least
every 2 years
|Make available to the NB (Notified Body)||Submit electronically to the NB|
|Make available to the Competent Authority on request||Made available to the Competent |
Authority by the NC
To summarize, the PMS is an ongoing review and risk assessment process throughout the medical device life cycle and should not be considered as a one-time project. Medical device startups and manufacturers should take the PMS process as a holistic approach to maximize the gains including fewer medical device defects, improved user safety, and, in certain cases, decreased litigation risks. The essential tools of your PMS process are proactive/reactive PMS and vigilance. When a medical device developer/manufacturer realizes that a PMS system is a quality control process for their medical device rather than just a regulatory requirement. The paraphernalia for this system consists of reactive and proactive elements and a demonstration/documentation of compliance. Proper implementation of the PMS is an integral and key component to a medical device’s success and PMS implementation procedures should reflect your commitment to data collection, review, and implementation.
Need help with medical device PMS? Take a look at post-market surveillance consultants on Kolabtree.
- MDR Chapter 1, Article 2 (60); IVDR Chapter 1, Article 2 (63).
- MDR Chapter VII Section 1/IVDR Chapter VII Section 1.
All articles in this series:
Medical Device Development and Design: A Definitive Guide
Medical Device Development: 3 Tips for Success
Medical Device Design: The Essential, Step-by-Step Guide
Medical Device Commercialization: 9 Steps from Sketch to Launch
How to Overcome Medical Device Commercialization Challenges
Medical Device Launch: Key Steps to Bring Your Product to Market
Medical Device Post-Market Surveillance: A Comprehensive Guide