Post Market Surveillance Under EU MDR
Post Market Surveillance (PMS) Under EU MDR
Introduction: The MDR'S Continuous Check Up
Congratulations, you have successfully obtained CE marking for your product! However, in the EU Medical Device Regulation world, this is just a starting point for the continuous monitoring of your medical device once it goes into production. Welcome to the Post Market Surveillance world!
Post Market Surveillance can be seen as a compulsory lifelong check up that your device requires to prove its compliance and safety throughout its entire lifecycle.
This activity is made mandatory and systematic by the MDR, which makes it the backbone of compliance and patient safety.
What Is PMS? (And Why Manufacturers Love It)
Post Market Surveillance as defined in the MDR are the actions performed by a manufacturer to establish and maintain a systematic procedure to proactively collect and analyze the experience of using devices placed on the market.
There are two main purposes for a robust Post Market Surveillance procedure:
Continuous improvement: data obtained from the procedures should be used to constantly update the technical documentation, clinical evaluation, and risk management.
Patient Safety: enables manufacturers to proactively detect the need for any preventive or corrective actions (including Field Safety Corrective Actions, FSCAs) to make the device safer and more efficient.
The Blueprint : Your Post Market Surveillance Plan
Each medical device manufacturer shall establish, document and maintain a Post Market Surveillance System in accordance with the Post Market Surveillance Plan (PMSP). Post Market Surveillance Plan is an integral part of the technical documentation of your device according to Annex III of the MDR.
What to Include in Your Post Marketing Surveillance Plan?
A PMSP is a strategic document that is supposed to be proactive and systematic and include all types of information collection activities:
Vigilance Data: information regarding serious incidents and Field Safety Corrective Actions (FSCAs).
Non Serious Incidents and Side Effects: records on non serious incidents and side effect information.
Trend Reports: information obtained from monitoring a significant trend of non serious incidents frequency and/or severity increase (Article 88).
Feedback and complaints: information, including feedback and complaints from users, distributors, importers.
Public Data: relevant specialist or technical literature, databases, registers and publicly available information related to other similar medical devices.
The Reporting Engine: PMSR VS. PSUR
The results of your Post Market Surveillance activities are summarized in safety reports of mandatory format with type depending on your risk class:
Device Risk Class | Required Report | Description |
|---|---|---|
Class I (Lowest Risk) | Post Market Surveillance Report (PMSR) | Summarises the results and conclusions of the PMS data analysis, including the rationale for and a description of any preventive and corrective actions undertaken. This report is regularly updated and shall be available to the competent authority on demand. |
Class IIa, IIb, and III (Higher Risk) | Periodic Safety Update Report (PSUR) | This document is more comprehensive in nature. The results and conclusions of PMS data will be provided with a focus on the benefit risk determination. The PSUR is sent to the Notified Body and is collected in the central database of medical devices in Europe (Eudamed). |
Post Market Clinical Follow Up (PMCF)
For many medical devices, particularly the higher classes of risk, PMS requires an essential element: Post Market Clinical Follow Up (PMCF).
PMCF is an ongoing process which aims at the updating of the clinical evaluation of the device. It comprises a proactive gathering and assessment of clinical data generated by the use of a CE marked device to demonstrate the continued safety and performance of a medical device, in particular concerning long term risks. It is the last part which proves that clinical data generated prior to market access were correct during the entire period of usage of a medical device.
Conclusion
Under the EU MDR Post Market Surveillance is not only about handling complaints. It is a proactive system which provides continuous flow of data back to the design, risk assessment and clinical evaluation of your device. An efficient PMS system is not a regulatory nightmare but the strongest proof of your commitment to long term patient safety and quality of your product.
How Morulaa Can Help
Morulaa can provide post market surveillance (PMS) support for your device according to the new EU MDR. We offer preparation of fully compliant PMS Plan, PMS Report, PSUR, PMCF Plan and PMCF Evaluation Report for your device. Our experts ensure proper flow of your real world data, vigilance input, complaint handling data and clinical data to your technical documentation.
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