EU MDR defines PMS 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”.
The PMS documents include:
| Document | Explanation | EU MDR Reference |
| PMS Plan | A well-defined plan specifying the process of collection and utilization of data related to serious / non-serious incidents, undesirable side-effects, trend reporting, feedback, complaints etc. | Article 84 Section 1.1, Annex III |
| PMS Report | Report summarising the results and conclusions of the analyses of the PMS data for Class I devices. | Article 85 |
| Periodic Safety Update Report (PSUR) | A summary of safety and performance of a Class IIa, IIb or III device evidenced through the data collected through PMS activities. | Article 86 |
Reporting timeline
| Document | Class I | Class IIa | Class IIb | Class III and implantable devices |
| PMS Plan | ✔ Yes | ✔ Yes | ✔ Yes | ✔ Yes |
| PMS Report | ✔ To be updated when necessary | ☓ | ☓ | ☓ |
| PSUR | ☓ | ✔ Every 2 years | ✔ Annually | ✔ Annually |
| Submission to Competent Authority | ✔ Upon request | ✔ Upon request | ✔ Yes | ✔ Yes |
| Submission to Notified Body | ☓ | ✔ Yes | ✔ Yes | ✔ Yes |
| EUDAMED | ☓ | ☓ | ☓ | ✔ Yes |
| End of PSUR requirement | Mandatory until end of the device lifetime defined in technical documents. | |||
In conclusion, Post-Market Surveillance is a fundamental component of EU MDR, ensuring that medical devices continue to meet safety and performance requirements throughout their lifecycle. With clearly defined documentation such as the PMS Plan, PMS Report, and PSUR, manufacturers are expected to proactively monitor and respond to real-world data. Compliance with PMS obligations not only fulfills regulatory requirements but also strengthens patient safety, supports continuous improvement, and builds trust in medical device performance over time.
How can RNCS help?
- Development of a PMS strategy tailored to device risk class and type
- Preparation of PMS documents which meet MDR requirements and MDCG guidelines
- Analysis of collected data and preparation of reports
- Updating PMS documents based on post-market data or design changes
- Integration of findings into risk management and clinical evaluation documents
- Preparation of responses to Competent Authorities and Notified Bodies
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
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