Post-Market Surveillance and Vigilance: MDR vs IVDR
PMS and vigilance are two halves of the same post-market system. PMS is the manufacturer’s proactive, continuous collection and review of data on its devices, while vigilance is the reactive duty to report serious incidents and field safety corrective actions to competent authorities within fixed deadlines. The MDR and IVDR handle both almost identically, with the same 2-, 10-, and 15-day reporting deadlines, but the IVDR uses different article numbers, its own A-to-D class system, post-market performance follow-up instead of PMCF, and a broader incident definition that covers harm caused by an incorrect test result.
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system that will increase safety and efficiency in the European medical device market; both include collecting clinical evidence and demonstrating an acceptable risk-benefit profile of medical devices, and; both set up strict post-market surveillance and vigilance requirements.
The IVDR has been harmonized with the MDR – particularly in regard to supply chain, clinical evaluations, and post-market requirements – compared to the In Vitro Diagnostic Device Directive (IVDD) that came before, making it easier for manufacturers to understand and comply with both regulations.
Although the general content of the two regulations is much the same, there are a few differences.
| EU MDR | EU IVDR | |
|---|---|---|
| Device types | Medical devices | In vitro diagnostic devices |
| Device classifications | Class I, Class IIa, Class IIb, and Class III | Class A, Class B, Class C, Class D |
| Clinical evidence | Clinical evaluation report based on clinical data | Performance evaluation report based on performance testing |
| Post-market follow-up | Post-market clinical follow-up | Post-market performance follow-up |
PMS vs Vigilance, MDR vs IVDR: Side by Side
TL;DR: PMS is proactive and continuous, vigilance is reactive and event-driven, and the MDR and IVDR differ mainly in article numbers, class systems, PSUR frequency, and the IVDR’s wider incident definition.
PMS vs vigilance
| Post-Market Surveillance (PMS) | Vigilance | |
| Nature | Proactive and continuous | Reactive and event-driven |
| Purpose | Collect and review real-world experience to identify any need for corrective or preventive action | Report serious incidents and FSCAs so authorities can assess and act |
| Trigger | Always running, from first device placed on the market | A serious incident, an FSCA, or a significant trend |
| Main outputs | PMS plan, PMS Report or PSUR, PMCF/PMPF | Incident reports (MIR), FSCA reports and Field Safety Notices, trend reports |
| Recipient | Technical documentation; notified body; competent authority on request | Competent authority (shared with the notified body) |
| MDR articles | 83–86, Annex III | 87–92 |
| IVDR articles | 78–81, Annex III | 82–87 |
MDR vs IVDR
| MDR (2017/745) | IVDR (2017/746) | |
| Risk classes | I, IIa, IIb, III | A, B, C, D |
| Lower-risk PMS output | PMS Report: Class I (Art. 85) | PMS Report: Class A and B (Art. 80) |
| Higher-risk PMS output | PSUR: Class IIa at least every 2 years; Class IIb and III at least annually (Art. 86) | PSUR: Class C and D at least annually (Art. 81) |
| PSUR submitted to notified body for evaluation | Class III and implantable devices | Class D devices |
| Clinical follow-up | Post-market clinical follow-up, PMCF (Annex XIV, Part B) | Post-market performance follow-up, PMPF (Annex XIII, Part B) |
| Serious incident and FSCA reporting | Art. 87 | Art. 82 |
| Reporting deadlines | 2 days (public health threat), 10 days (death or unanticipated serious deterioration), 15 days (other) | Same |
| Trend reporting | Art. 88 | Art. 83 |
| Incident definition | Malfunction, deterioration, use error from ergonomics, inadequate information, undesirable side effect | Same, plus harm resulting from a medical decision, or action taken or not taken, based on the device’s result |
| Authority market surveillance | Art. 93 | Art. 88 |
For a closer look at where PMS ends and vigilance begins, see PMS vs Market Surveillance vs Vigilance. For how CiteMed handles vigilance monitoring and reporting across both regulations, see CiteMed Vigilance.
Post-Market Surveillance and vigilance in the Medical Device Regulation
Under the MDR, PMS produces a PMS Report or PSUR plus PMCF, and vigilance covers reporting serious incidents and FSCAs to competent authorities.
Post-Market Surveillance (PMS) is defined in the European medical device regulation as “all activities carried out by the manufacturer… to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market”.
The MDR framework for post-market surveillance is the reference point for all device classes, and our main guide to post-market surveillance under EU MDR sets out exactly what’s required.
It is the single most important tool in medical device manufacturers’ toolbox to analyze and document any and all adverse events happening in situations where devices are included, and it is a mandatory process under practically every medical device regulation in the world.
Post Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR)
One of the new initiatives in the MDR compared to the MDD is the requirement to prepare Post Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) for medical devices – This requirement has previously only been present in the pharmaceutical world.
Of these two reports, the PMSR applies only to low-risk Class I devices and should only be provided to the authorities on request. The PSUR applies to Class IIa, Class IIb, and Class III devices; it must be updated at least annually for Class IIb and III devices and at least every two years for Class IIa devices.
Post Market Clinical Follow-up (PMCF)
Besides the PMSR and PSUR reports, a Post Market Clinical Follow-up (PMCF) report should also be elaborated as part of the concept of continuous clinical evaluation and lifecycle management of your medical device. The PMCF requirements are stricter and more intense than under the MDD and the guidance for PMCF has been reinforced and expanded.
Vigilance reporting
Last, but not least, vigilance reporting must be a strong component of any Post Market Surveillance program and medical device vigilance system. When actions are taken to reduce the risk of harm and/or serious deterioration of health by the manufacturer as part of their adverse event reporting program, it is the responsibility of the manufacturer (or the Authorized Representative) to report these actions to the competent authorities in the afflicted markets. Failure to report a Field Safety Corrective Action and present vigilance reports can result in serious legal consequences.
Post-Market Surveillance and vigilance in the In Vitro Diagnostic Medical Device Regulation
The IVDR uses the same PMS definition and structure, with PMS Reports for Class A and B, PSURs for Class C and D, and PMPF in place of PMCF.
Post Market Surveillance (PMS) is defined in the European in vitro diagnostic device regulation almost identically as in the MDR. Post-market surveillance is defined as “all activities carried out by the manufacturer… 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.”
Post Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR)
As in the MDR, the IVDR demands Post Market Surveillance Reports (PMSR) for all Class A and B IVDs, and Periodic Safety Update Reports (PSUR) for Class C and D IVDs.
Class C and D PSURs must be updated at least annually. For Class D devices, the PSUR is submitted to the notified body for evaluation; for Class C, it is made available to the notified body.
Post Market Clinical Follow-up (PMCF)
The clinical evaluation report – so well-known for medical devices – should be substituted for a performance evaluation report for IVDs, as clinical evidence for in vitro diagnostic medical devices is demonstrated through performance evaluations, not clinical evaluations. The post-market clinical follow-up for IVDs is also substituted for a post-market performance follow-up report (PMPF).
Since the risk of in vitro diagnostic medical devices depends so much on the device type, the post-market surveillance requirements are not as defined as they are for medical devices – a Class A IVD will require different post-market surveillance activities than a Class D IVD.
Vigilance reporting
Vigilance activities work much the same for IVDs as they do for medical devices – the manufacturer must notify the national competent authority of any actions taken to reduce the risk of harm and/or serious deterioration of health, such as field safety corrective actions, within the established timelines.
One genuine difference worth stating here: the IVDR’s definition of an incident also covers any harm resulting from a medical decision, or from an action taken or not taken, based on information or results provided by the device. A false negative that delays treatment can therefore be a reportable incident even if the device never physically malfunctioned.
So, what are the actual differences in regard to post-market surveillance and vigilance in the MDR vs IVDR?
The structure and vigilance deadlines are the same; the differences are in article numbers, class systems, PSUR frequency, PMPF versus PMCF, and the IVDR’s broader incident definition.
The short answer is that there are very few. Both regulations require robust, proactive post-market surveillance and vigilance systems and set identical vigilance reporting deadlines. The differences are in article numbering, the risk class systems, PSUR update frequency, PMPF in place of PMCF, and the IVDR’s broader definition of an incident.
| EU MDR | EU IVDR | |
|---|---|---|
| Post-market surveillance report (PMSR) | Required for Class I manufacturers – updated when necessary | Required for Class A and Class B manufacturers – updated when necessary |
| Periodic safety update report (PSUR) | Required for Class IIa, Class IIb, and Class III manufacturers – updated at least annually | Required for Class C and Class D manufacturers – updated at least annually |
| Post-market follow-up | Post-market clinical follow-up (PMCF) report | Post-market performance follow-up (PMPF) report |
| Vigilance reporting | Serious threat to public health: No later than 2 days Death or serious deterioration of health: No later than 10 days Serious incident: No later than 15 days | Serious threat to public health: No later than 2 days Death or serious deterioration of health: No later than 10 days Serious incident: No later than 15 days |
The differences can be found in the minor details of the post-market surveillance and post-market follow-up requirements, such as the specific content of the reports, as this depends on your device type and risk classification.
Both regulations entered into force in May 2017. The MDR has applied since May 26, 2021, and the IVDR since May 26, 2022. Legacy devices certified under the old directives now have extended transition periods under both regulations, running to December 31, 2028 for most MDR legacy devices and to December 31, 2029 for some IVDR legacy devices, provided the manufacturer met the required notified body application deadlines.
Notified body capacity for IVDs still lags behind medical devices. The European Commission’s notified body survey, with data as of February 28, 2026, counted 52 notified bodies designated under the MDR and 19 under the IVDR (some hold both designations). Check the NANDO database for the current list.
As a manufacturer of medical devices and in vitro diagnostic devices, you will find the MDR and IVDR harmonized and similar in regard to post-market surveillance and vigilance requirements. The differences lie in the subtleties, so if you manufacture both types of devices you will need to study the two regulations carefully to point out the differences and comply with both regulations.
FAQ
What is the difference between PMS vs vigilance?
PMS is the proactive, always-on system a manufacturer uses to collect and review experience with its devices. Vigilance is the reactive part of that system: reporting serious incidents, FSCAs, and significant trends to competent authorities within fixed deadlines. See PMS vs Market Surveillance vs Vigilance for a fuller comparison.
Are post market surveillance vs vigilance requirements different under MDR and IVDR?
Very little. Both regulations use the same PMS definition, the same PMS plan structure in Annex III, and the same 2-, 10-, and 15-day vigilance deadlines. The differences are in article numbers, risk classes, PSUR frequency, PMPF instead of PMCF, and the IVDR’s broader incident definition.
What are the MDR vs IVDR surveillance requirements for PSURs?
Under the MDR, Class IIb and III devices need a PSUR at least annually and Class IIa at least every two years. Under the IVDR, Class C and D devices need a PSUR at least annually. Lower-risk devices under both (MDR Class I, IVDR Class A and B) need a PMS Report instead.
Are vigilance reporting deadlines the same under MDR and IVDR?
Yes. Serious public health threats must be reported within 2 days, deaths or unanticipated serious deterioration in health within 10 days, and all other serious incidents within 15 days of the manufacturer becoming aware.
What is PMPF and how does it differ from PMCF?
Post-market performance follow-up (PMPF) is the IVDR’s equivalent of post-market clinical follow-up (PMCF). Instead of updating a clinical evaluation, it updates the device’s performance evaluation, which covers scientific validity, analytical performance, and clinical performance.
Where does market surveillance fit in?
Market surveillance is done by national competent authorities, not manufacturers, under MDR Article 93 and IVDR Article 88. It involves checking device conformity, inspecting facilities, and acting on unsafe or falsified devices. Our main PMS guide covers it in detail.