Structured. Compliant. Permanently fulfilled.
Post-Market Surveillance (PMS) & Vigilance
Manufacturers’ regulatory responsibility does not end after Medical Devices are placed on the market. PMS is mandatory, ongoing – and often fraught with uncertainty. We support manufacturers of Medical Devices and In Vitro Diagnostic Devices in fulfilling PMS and Vigilance requirements in a structured and transparent manner – without unnecessary additional effort.
“What do I have to do if an incident occurs after the device has been placed on the Market?”
This is exactly where the greatest uncertainties arise: reporting obligations, deadlines, communication with authorities – and the question of whether a report is required or not. We provide clarity, assess systematically, and guide you through the necessary steps.
Our services in the area of PMS & Vigilance
PMS report & documentation
- Your PMS plans and reports are complete, review-ready, and up to date
- The Periodic Safety Update Report (PSUR) and PMS report are prepared in a regulatory-compliant manner and updated on schedule
- Trend analyses and signal detection are documented in a structured and audit-ready manner
Vigilance
An incident has occurred – and you need to decide quickly: is this a Reportable Event? We support you with the assessment and ensure that action is taken correctly and within deadlines.
- An incident has occurred. You can decide quickly, and within deadlines, whether a report is required, as well as what needs to be reported
- Deadlines, reporting channels, and responsibilities are clear – no uncertainty in an emergency
- Serious incidents, trend reports, and Field Safety Corrective Actions (FSCAs) are reported expertly
- Communication with authorities in Vigilance proceedings is conducted in a structured and reliable manner
Integration & continuity
- PMS is seamlessly integrated into your Quality Management System and your CAPA processes
- Interfaces to Clinical Affairs, risk management, and Technical Documentation are consistently mapped
- With the PMS Update Service, Vigilance and PMS requirements remain permanently up to date
Vigilance and PMS requirements change continuously – in over 70 countries. Our Update Service keeps you current:
→ Update Services
PMS data feed directly into Clinical Evaluation and Performance Evaluation. Learn more:
→ Clinical Affairs
When it really matters, every hour counts.
Whether individual case or ongoing support – we support you exactly where uncertainty arises.
Schedule a free initial consultationWhen manufacturers come to us
An incident has occurred
Reporting requirements, deadlines, and next steps must be clarified quickly.
Set-up or stabilize the PMS system
Structures, templates, and processes must be established or updated.
Ongoing support
PMS Reports, Vigilance notifications, and trend analyses should be continuously managed.
Our services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about PMS & Vigilance
PMS (Post-Market Surveillance) is the overarching, continuous process of collecting and evaluating all data related to the safety, performance, and quality of a product after placing on the market. Vigilance is a part of this process – it focuses specifically on reporting serious incidents and Field Safety Corrective Actions (FSCAs) to the Competent Authorities. In short: PMS is the system; Vigilance is the reporting system within that system.
For IVDs: manufacturers of classes A and B prepare a PMS Report, which must be made available to the authority upon request. For classes C and D, the PSUR is regularly submitted to the Notified Body.
The PSUR is mandatory for products of classes IIa, IIb, and III. For class IIa products, it must be updated at least every two years; for classes IIb and III, annually. For IVDs of classes C and D, the PSUR is also mandatory – annually in each case. It must be accessible to the Notified Body and can be requested by authorities at any time. Additionally, manufacturers of class III products, implants, and IVDs of class D must proactively upload the PSUR to EUDAMED. We support you with preparation, structuring, and timely updates.
An FSCA is a Field Safety Corrective Action that a manufacturer takes to reduce or eliminate a potential serious deterioration of health or death caused by a product already placed on the market – for example, a recall or product replacement. FSCAs must be reported to the Competent Authorities before they are implemented – unless there is an immediate hazard. We support you with the assessment, reporting, preparation of the Field Safety Notice (FSN), and communication.
The deadlines depend on the regulatory requirements of the individual countries. The following applies to the EU market:
Serious incidents with serious deterioration of health:
15 days
Serious incidents resulting in death or unexpected Serious incidents:
10 days
Serious public health threat: immediately, no later than 2 days
immediately, within 2 days at the latest
Internationally, deadlines vary considerably in some cases. We help you act quickly and correctly – regardless of the market.
To ensure you do not miss international deadlines:
→ Vigilance Update Service
A missing or insufficient PMS system can lead to delays in the certification process, a delivery stop, or regulatory sanctions. Defective or insufficient PMS systems are among the most common causes of audit nonconformities. We support you in building your PMS system so that it is regulatory-robust and manageable in daily practice.
To prevent PMS requirements from becoming a recurring issue – our Update Service provides the right solution: → Update Services
When an incident occurs, there is no time to set up processes from scratch. We ensure that your PMS and Vigilance system are in place before you need them – and that you know what to do in an emergency.