MDCG 2025-10: Guidance on Post-Market Surveillance of Medical Devices and IVDs
Document: MDCG 2025-10
Year: 2025
Published: 19 December 2025
Regulation: EU MDR 2017/745 / EU IVDR 2017/746
Official PDF: Download
Purpose
This guidance provides a comprehensive description of the Post-Market Surveillance (PMS) system required under the EU MDR (Article 83) and IVDR (Article 78). It clarifies expectations for PMS plans, main PMS activities, and the interactions between PMS and other key aspects of the Quality Management System (QMS).
Key Points
- PMS as a continuous, proactive system: PMS is not a reactive checklist but a continuous, structured system embedded within the manufacturer's QMS. Surveillance begins when the first device is placed on the market and continues until the end of the intended lifetime of the last device.
- Proactive data collection: Manufacturers must actively seek out information and not merely wait for complaints. This includes customer surveys, clinical experience, user feedback, literature screening, registries, and post-market studies.
- PMS Plan requirements: Each device or device group must be covered by a PMS plan that specifies methods, data sources, frequencies, threshold values, trend reporting methodology, and PMCF/PMPF plans.
- Indicators and threshold values: Suitable indicators and thresholds must be established pre-market and used for continuous reassessment of the benefit-risk ratio.
- Trend reporting: The PMS plan must outline statistical methods for detecting any statistically significant increase in frequency or severity of non-serious incidents, as well as observation periods and reporting procedures.
- QMS integration: PMS data must actively drive decisions and feed into risk management, clinical/performance evaluation, design and labelling updates, SS(C)P, CAPA, and management review.
- Custom-made devices: PMS requirements under Article 83 MDR apply to custom-made devices; PMCF plans are required.
- One plan for multiple devices: A single PMS plan can cover devices with the same manufacturing process, design, intended purpose, or device family.
- SOTA assessment: PMS data should be used to confirm the device remains consistent with the generally accepted State of the Art.
- Top management reporting: The effectiveness of the PMS system should be reported to top management, e.g., via management review.
Structure
| Section | Content |
|---|---|
| 1 | Introduction |
| 2 | Scope and Objectives |
| 3 | The PMS System required by MDR/IVDR (general obligations + custom-made devices) |
| 4 | The PMS plan (Table 1: elements required per Annex III) |
| 5 | Main activities of the PMS system (data sources, collection, assessment, conclusions) |
| 6 | Interactions of PMS with other QMS aspects (Table 3: risk management, clinical evaluation, SS(C)P, CAPA, design, trend reporting) |
| 7 | References |
| Annex 1 | Overview of PMS obligations in MDR and IVDR |
| Annex 2 | Scenarios: IVD and medical device examples of PMS data utilization |
Relationship to Other MDCG Documents
| Document | Relationship |
|---|---|
| MDCG 2022-21 | PSUR guidance -- MDCG 2025-10 does not cover PSUR/PMS report preparation; refers to MDCG 2022-21 |
| MDCG 2020-7 | PMCF Plan Template -- referenced for PMCF/PMPF plan requirements |
| MDCG 2023-1 | Health institution exemption (out of scope of MDCG 2025-10) |
| MDCG 2023-3 | Vigilance terms and concepts -- referenced for serious incident reporting |
| MDCG 2021-3 | Custom-made devices Q&A -- referenced for CMD PMS obligations |
| MDCG 2024-1 | Device Specific Vigilance Guidance (DSVG) Template |
Key Standards Referenced
- EN ISO 13485:2016 (Quality management systems)
- EN ISO 14971:2019 (Risk management)
- CEN ISO/TR 20416:2020 (Post-market surveillance for manufacturers)
Official Full Text
See fulltext/mdcg-2025-10 for the complete guidance text.