Manufacturer Incident Report (MIR) Form 7.3.1 Updated: Mandatory May 1, 2026
29 December 2025
December “In All Other News”: Draft Act to Revise NB Requirements, New MDCG Docs, & more
7 January 2026The Medical Device Coordination Group (MDCG) published MDCG 2025-10 in December 2025: HERE
The guidance clarifies post-market surveillance (PMS) requirements under Article 83 of the MDR and Article 78 of the IVDR. This includes, notably, expectations around what ‘proactive’ means in the context of PMS.
Note: it does not cover drafting PMS Reports (Class I devices, Class A and B IVDs) or PSURs (all other classes). For PSURs, refer to MDCG 2022-21. A specific MDCG guidance on PMS Reports does not exist yet, but MDCG 2022-21 can be used for reference.
Highlights from MDCG 2025-10
Below we provide an overview of some notable items. The guidance contains good information on how to draft a strong PMS Plan; we recommend reading it in full.
Device Development and PMS Planning
Manufacturers should not wait until market launch to think about PMS. Instead, planning should begin during device development.
Manufacturers should determine early on which activities will be needed to systematically and proactively collect experience gained from devices once they’re on the market.
PMS is a Continuous Process
The guidance emphasizes that PMS should not be treated as a “checkmark” item to get past. Instead:
- The PMS cycle begins when the first device is placed on the market or put into service
- Surveillance activities must continue throughout the entire period, until the end of the intended lifetime of the last device placed on the market
- Data collection must be systematic, ongoing, and recorded continuously
- Each cycle concludes with a report (PMS Report or PSUR, depending on class)
- The report then informs updates to your PMS plan, technical documentation, and other relevant files for the next cycle
This helps creates a continual cycle for device monitoring and improvement.
PMS and Top Management
The effectiveness of your PMS system should be reported to top management, for example, through management review. This is to reinforce that PMS is a QMS-level process that needs visibility and accountability at the top management level.
What “Proactive” Means
The concept of “proactive” is central to PMS and highlighted throughout MDCG 2025-10.
The guidance reiterates that manufacturers must actively seek out available information, i.e., they cannot simply wait for it to arrive through reactive channels, like complaints.
Examples of proactive data collection include:
- Customer surveys
- Gathering clinical experience and user feedback
- Screening scientific literature
- Reviewing other clinical data sources
- Evaluating suitable clinical or device registries for relevant real-world data
- Running post-market studies, where appropriate
The guidance acknowledges that complaints and vigilance reports are necessary, but insufficient on their own as PMS data.
Manufacturers are responsible for identifying the level of data required for adequate PMS reporting. It should be proportionate to the risk level of the device.
One Plan for Multiple Devices
Each device must be covered by a PMS plan. However, a separate plan is not necessarily required for every single device.
A single PMS plan can cover:
- Devices with the same manufacturing process
- Devices with the same design and intended purpose
- Devices in the same device family
The PMS plan must clearly state which devices are included in its scope.
MDCG 2022-21 also addresses this as part of drafting the PSUR, and best practices if doing so, e.g., identifying the leading device.
PMS Data Should Assess Device Performance
Data collected through PMS should be used to:
- Analyze and characterize device performance
- Enable comparisons with similar devices
- Confirm the continued acceptability of the benefit-risk ratio
- Show your device’s performance compared to the generally accepted state-of-the-art (SOTA), taking into consideration “datasets from different patient populations, device combinations, and models/variants”
If your analysis reveals previously unknown side effects or device deficiencies, follow your risk management processes.
Trend Reporting Requirements
The PMS plan must outline the methodology the manufacturer will use to detect and report trends. Trend reporting is required for non-serious incidents and expected undesirable side effects (MDR) or expected erroneous results (IVDR).
Specifically, the PMS plan should document:
- Statistical methods for determining any statistically significant increase in frequency or severity, i.e., how will you determine that complaints or incidents are happening more often or getting worse, compared to what you normally expect?
- Threshold values and indicators that will trigger trend reporting, i.e., at what point is the increase ‘significant’?
- That incident and complaint data are systematically collected and monitored for trends on an ongoing basis, with formal statistical trending performed at predefined intervals, e.g., monthly or quarterly, proportionate to device risk, usage volume, and intended use.
- Procedure for submitting trend reports.
The above is required under Article 88 MDR and Article 83 IVDR. However, manufacturers sometimes overlook the need to proactively define this methodology in the PMS plan, rather than waiting until a potential trend emerges.
Custom-Made Devices Require PMS
The guidance confirms that Article 83 MDR requirements apply to custom-made devices (CMDs). And that while Article 84 MDR doesn’t explicitly state that the PMS plan should be part of CMD documentation, the obligation still exists.
This means:
- CMDs need a PMS plan, i.e., they are not exempt.
- Post-market review focuses mainly on expected performance; therefore, a PMCF plan is generally required.
- CMD manufacturers should establish communication channels with relevant healthcare providers, professionals, or patients to receive feedback on quality, performance, clinical performance, and safety.
- Apply PMS, risk management, and clinical evaluation lifecycle processes to groups of devices with the same intended purpose, materials, processes, and principal design. You don’t need to do this for each individual CMD.
- Your PMS plan should clearly state which CMDs placed on the market are covered.
Resources Within MDCG 2025-10
The guidance includes several tables/annexes that are worth reviewing:
- Table 1 (pages 8-9): provides a detailed breakdown of all elements required in a PMS plan per Annex III of the MDR/IVDR. This table explains each requirement and gives examples of what content should appear in the plan.
- Table 2 (pages 11-12): breaks down the information sources listed in Annex III, explaining what types of information should be collected from each source and how that information should be used.
- Table 3 (pages 15-17): details how PMS data should interact with other QMS processes like risk management, clinical evaluation, SSCP updates, and CAPA. This table helps visualize how the PMS system functions within the QMS.
- Annex 1 (pages 20-21): summarizes PMS obligations across the MDR and IVDR. This covers the PMS system, PMS plan, PMS reports, and PSURs.
- Annex 2 (pages 22-23): provides real-world examples of how PMS data lives in the QMS. E.g., an IVD workflow for blood glucose test strip failures, from incident reports through investigation, FSCA, and process improvements. And a medical device workflow for battery depletion issues in implantable defibrillators, and the resulting updates to risk management, clinical evaluation, and design documentation.
