PMS vs Vigilance: What Is the Difference?
Post-market surveillance (PMS) is the manufacturer’s proactive, always-running system for collecting and reviewing data on its devices once they are on the market. Vigilance is the reactive part of that system: when a serious incident happens or a field safety corrective action is taken, the manufacturer must report it to the competent authority within 2, 10, or 15 days depending on severity. Put simply, PMS looks for problems and vigilance reports them; market surveillance is a third activity carried out by regulators, not manufacturers.
| Post-Market Surveillance (PMS) | Vigilance | |
| The question it answers | Is the device still safe and performing as intended? | Has something gone wrong that authorities must know about? |
| Approach | Proactive: the manufacturer actively seeks out data | Reactive: triggered by a specific event |
| When it runs | Continuously, for the device’s whole life on the market | When a serious incident, FSCA, or significant trend occurs |
| Main outputs | PMS plan, PMS Report or PSUR, PMCF | Serious incident reports, FSCA reports and Field Safety Notices, trend reports |
| Who receives it | Technical documentation, reviewed by the notified body | The competent authority |
| Deadlines | Report update cycles (e.g. PSUR annually for Class IIb and III) | 2, 10, or 15 days from awareness |
| MDR articles | Articles 83–86 | Articles 87–92 |
For how these rules compare under the MDR and IVDR, see Post-Market Surveillance and Vigilance: MDR vs IVDR. For the full vigilance guide and reporting tools, see CiteMed Vigilance.
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity from the two other surveillance activities?
Don’t fret! Today, we are exploring post-market surveillance, market surveillance, and vigilance, and telling you all about how they are different.
Post-market surveillance (PMS)
PMS is the manufacturer’s proactive, systematic collection and review of experience with its devices on the market, used to spot any need for corrective or preventive action.
What is it?
Post-market surveillance is the activities carried out by a medical device or in vitro diagnostic (IVD) manufacturer to ensure their device’s safety, efficiency, and compliance in the market.
Other economic operators, such as distributors or importers, might be responsible for acting on behalf of the manufacturer in post-market surveillance activities.
(MDR; 2017/745). Same fix in the market surveillance definition further down, if that section is kept.
Post-market surveillance is defined in the European Medical Device Regulation (MDR; 745/2017) as:
“…all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;“.
For the full requirements, see our main guide to post-market surveillance under EU MDR.
What does it entail?
Post-market surveillance activities include drafting a post-market surveillance plan, collecting and analyzing data on the market behavior of medical devices, using that data in risk management and connected quality management system processes, implementing field safety corrective actions and preventive actions if required, and maintaining a post-market clinical follow-up and periodic safety update report where necessary.
The post-market surveillance system for medical device manufacturers must be a proactive and systematic process, meaning that medical device manufacturers must actively search for the information required to fulfill their post-market surveillance objectives.
User/patient feedback
Collecting feedback from users and patients is of utmost importance to be aware of the behavior of medical devices in the market.
Your post-market surveillance system must be set up so user feedback is encouraged, adequately gathered and analyzed, and subsequently implemented.
Other sources of post-market surveillance information are device services, medical device registries, post-market clinical follow-up, clinical data from literature reviews, user training, public and social media, clinical evaluation, quality management system audits, and many more.
Corrective and preventive actions
When PMS data reveals a serious incident or a significant trend, reporting it to the competent authorities is the vigilance part of the process. The PMS side is making sure the underlying problem is fixed and does not happen again.
The cause of the non-conformity must be removed (corrective action), and it must be ensured that the non-conformity does not occur again (preventive action). These processes should be an integral part of all your post-market surveillance processes.
Market surveillance
Market surveillance is carried out by national competent authorities, not manufacturers, to check that devices on the market comply with the regulation.
Market surveillance is the third, separate activity. It is carried out by national competent authorities, not manufacturers, under Article 93 of the MDR. Authorities check that devices on their market comply, inspect manufacturers and distributors, review the incident reports that manufacturers submit through vigilance, and can require corrective measures or withdraw unsafe and falsified devices. For the full picture, see the market surveillance section of our main PMS guide.
Vigilance
Vigilance is the manufacturer’s duty to report serious incidents, field safety corrective actions, and significant trends to competent authorities within fixed deadlines.
Any serious incident involving a device made available in the European Union, and any field safety corrective action taken in the EU or in a third country for a device that is also on the EU market, must be reported to the relevant national competent authority. Until the EUDAMED vigilance module becomes mandatory, this is done through national procedures using the Manufacturer Incident Report (MIR) form.
The timelines for reporting depend on the severity of the incident and the danger to the public:
- Serious incidents should be reported no later than 15 days after the manufacturer has become aware of the incident
- Serious incidents involving death or an unanticipated serious deterioration in a person’s health should be reported no later than ten days after the manufacturer has become aware of the incident
- Serious public health threats should be reported no later than two days after the manufacturer has become aware of the threat
Part of vigilance reporting is the newly implemented requirement of trend reporting.
Trend reporting was not a significant part of the European Medical Device Directive (MDD; 93/42/EEC) but recently became an obligation under the European MDR.
To be able to report trends, data must be collected from your own products and similar products to produce graphics and data on how your device is behaving compared to similar medical devices in the market.
Any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or of expected undesirable side effects, must be reported to the competent authority as a trend report under Article 88. The PMS plan must set out the statistical method and observation period used to detect such trends, and the PMS Report or PSUR should summarise any trends found and the actions taken.
Post-market surveillance, market surveillance, and vigilance are all parts of the same coin.
They are all designed to ensure the safety, efficiency, and compliance of medical devices available in the market.
They set out to establish a plan to monitor and evaluate the device’s behavior in the market and ensure it continues improving.
While post-market surveillance is not easy, it is critical to ensure your device is compliant and safe for users.
Furthermore, medical devices must constantly be updated and improved upon to stay on the market and continue to be relevant. Post-market surveillance can help manufacturers do just that.
How PMS and Vigilance Work Together
Vigilance sits inside PMS: PMS finds and evaluates the signal, vigilance reports it, and PMS then feeds what was learned back into the device’s documentation.
A single complaint shows how the two connect. The complaint enters the PMS system and is investigated. If it turns out to be a serious incident, the vigilance clock starts and the manufacturer reports it within the applicable deadline, followed by an FSCA if one is needed. The findings then return to PMS, where they update the risk management file, the clinical evaluation, the instructions for use if needed, and the next PMS Report or PSUR. Treating vigilance as a separate process that runs outside PMS is one of the most common reasons incidents are reported late.
Post-market surveillance, market surveillance, and vigilance are all parts of the same coin.
They are all designed to ensure the safety, efficiency, and compliance of medical devices available in the market.
They set out to establish a plan to monitor and evaluate the device’s behavior in the market and ensure it continues improving.
While post-market surveillance is not easy, it is critical to ensure your device is compliant and safe for users.
Furthermore, medical devices must constantly be updated and improved upon to stay on the market and continue to be relevant. Post-market surveillance can help manufacturers do just that.
FAQ
What is the PMS vs vigilance difference in one sentence?
PMS is the proactive, continuous collection and review of data on a device on the market, while vigilance is the reactive duty to report serious incidents, FSCAs, and significant trends to competent authorities within fixed deadlines.
Is vigilance part of post-market surveillance?
Yes. Vigilance is one component of the wider PMS system: the PMS plan has to describe how incidents are identified and escalated, and vigilance data feeds back into the PMS Report or PSUR. The post market surveillance vigilance difference is about scope and trigger, not two unrelated processes.
What is the difference between MDR vigilance vs surveillance requirements?
Under the MDR, surveillance (PMS) requirements sit in Articles 83 to 86 and Annex III and cover the PMS system, plan, and periodic reports. Vigilance requirements sit in Articles 87 to 92 and cover incident reporting, FSCAs, trend reporting, and the analysis of those reports by authorities.
What are the vigilance reporting deadlines?
No later than 2 days for a serious public health threat, 10 days for a death or unanticipated serious deterioration in health, and 15 days for any other serious incident, counted from when the manufacturer becomes aware. See CiteMed Vigilance for how these are tracked in practice.
Is market surveillance the same as post-market surveillance?
No. Post-market surveillance is done by the manufacturer on its own devices; market surveillance is done by national competent authorities across the whole market. Our main PMS guide covers market surveillance in detail.
Do PMS and vigilance work differently for IVDs?
The concepts are the same, with a few differences in article numbers, classes, and the definition of an incident. See Post-Market Surveillance and Vigilance: MDR vs IVDR for the side-by-side comparison.