EU IVDR & MDR Post Market Surveillance (PMS)

EU Post Market Surveillance (PMS) under MDR & IVDR

Under the European Medical Device Regulation (MDR) EU 2017/745 and the In Vitro Diagnostic Regulation (IVDR) EU 2017/746, manufacturers are required to implement and maintain a robust Post-Market Surveillance (PMS) system for all medical devices and in vitro diagnostic devices, regardless of their classification. PMS activities are essential for continuously monitoring the safety and performance of devices once they are available on the market.

Quick facts about Post Market Surveillance requirements: 

• Mandated under MDR 2017/745, Article 83
• Mandated under IVDR 2017/746, Article 78
• Applied to all risk classes, from Class I to Class III and Class A to D for IVDs, with specific deliverables depending on the risk classification:
  • PMS Plan is required for every device
  • PMS Report is required for Class I MDs and Class A and B IVDs.
  • PSUR Report is required for Class IIa, IIb and III MDs and Class C and D IVDs

How NAMSA Can Help You Meet Post Market Surveillance Requirements

Step 1: Define and Write your PMS Plan

The Post-Market Surveillance (PMS) Plan is a regulatory requirement under EU MDR Article 84 and IVDR Article 79, and must be included in your technical documentation as outlined in Annex III. It defines how you will proactively and systematically monitor the safety and performance of your device or IVD once it is on the market.

While the regulations specify what must be included, they don’t explain how to build a plan that meets Notified Body expectations. That’s where NAMSA can help.

Our regulatory and medical writing teams have supported manufacturers globally in developing PMS Plans that are not only compliant, but also practical and inspection-ready. We will create a PMS Plan that clearly outlines how you will:

• Collect and assess data proactively and systematically, including complaints, vigilance reports, literature, and registry data, among others
• Gather information of the manufacturer´s device and similar devices, to allow characterization and comparison of device performance
• Define indicators and thresholds to reassess the benefit-risk ratio and risk management
• Investigate complaints and field experience using effective tools and protocols
• Monitor trends and statistically significant increases in incident frequency or severity
• Communicate effectively with authorities, Notified Bodies, economic operators, and users
• Identify and initiate corrective actions, including CAPAs and field safety notices
• Trace affected devices in case of safety actions
• Include a PMCF or PMPF Plan

Step 2: Write your PMS Report or PSUR

Once your PMS Plan is in place, the next step is to generate the appropriate Post-Market Surveillance output—either a Post Market Surveillance Report or a Periodic Safety Update Report (PSUR), depending on your device classification.

Post Market Surveillance Report (PMS Report)

Post Market Surveillance Report is simplified a post-market summary required for lower-risk devices (Class I MDs and Class A/B IVDs). It must be updated when necessary and kept available for review by competent authorities.

While the format is less prescriptive than the PSUR, it still needs to demonstrate that you are actively monitoring your device’s performance and safety. NAMSA will help you prepare a PMS Report that clearly shows how you have implemented all the activities described in your PMS plan, including:

• Collect and assess post-market data from complaints, user feedback, and vigilance systems, amongst others
• Summarize findings related to safety, performance, and any corrective actions taken
• Justify the continued conformity of your device with applicable requirements
• Document updates to your risk management and clinical/performance evaluation

Our team ensures your Post Market Surveillance Report is structured, traceable, and aligned with regulatory expectations.

Periodic Safety Update Report (PSUR)

The Periodic Safety Update Report (PSUR) is a regulatory requirement under EU MDR Article 86 and IVDR Article 81, designed for moderate- to high-risk devices (Class IIa, IIb, III MDs and Class C/D IVDs). It provides a structured, recurring overview of a device’s safety and performance once it is on the market. At NAMSA, our regulatory and medical writing teams have supported manufacturers globally in preparing PSURs that are complete, compliant, and ready for review. We will help you develop a PSUR that clearly demonstrates how you have identified and evaluated any changes of the benefit-risk ratio, with details of any CAPAS involved. The PSUR will tipically include:

• Description of devices, and a rationale for groupings when several devices are grouped
• Analysis of serious incidents, CAPAs, Field Safety Corrective Actions and trend data, including statistically significant increases in adverse events
• Sales and estimates of patient exposure using sales data and usage assumptions, even for reusable devices
• PMCF or PMPF findings to support your benefit-risk conclusions
• Conclusions about the reliability of the collected data, noting any limitations, and a discussion of the resulting benefit–risk ratio and whether it remains acceptable and aligned with your risk management documentation

Whether you’re preparing your first PSUR or updating an existing one, NAMSA ensures your report is structured, evidence-based, and and ready for inspection, whether you’re preparing for a routine audit or responding to a regulatory inquiry.