|
PMS Under IVDR: Keeping Your IVD Safe After Launch
|
|---|
|
Post-Market Surveillance (PMS) means keeping watch on your IVD after it is sold and used in real life. PMS isn’t new (IVDD already expected manufacturers to collect post-production information), but IVDR 2017/746 makes PMS much more detailed and strictly enforced. The goal is simple: make sure the device continues to be safe and perform as claimed, even when used in different labs, users, and patient groups. |
INTRODUCTION
Post-Market Surveillance (PMS) is not a novel concept for manufacturers of in vitro diagnostic (IVD) devices. The earlier directive, IVDD (98/79/EC), had already introduced the need for a structured method to monitor and evaluate device performance after it has been released to the market. Specifically, Annex III, Section 5 of the IVDD emphasized the importance of collecting and analyzing post-production data to ensure ongoing safety and effectiveness. Additionally, PMS principles were supported through international standards such as ISO 13485, which outlines requirements for a quality management system for medical devices, and ISO 14971, which focuses on risk management throughout a device’s lifecycle. However, the IVDR (2017/746) brings a significant shift in PMS expectations. It introduces more detailed, rigorous, and clearly defined obligations. These new requirements are part of a broader effort to enhance transparency, improve patient safety, and ensure that IVD devices continue to meet performance expectations throughout their use in the field.
WHY PMS IS IMPORTANT UNDER IVDR
Under the EU IVDR 2017/746, Post-Market Surveillance (PMS) is a mandatory regulatory requirement that aims to monitor the safety and performance of IVD devices once they are on the market. The importance of PMS lies in several key areas:
- Detecting previously unidentified risks: PMS helps identify new safety concerns or performance issues that were not evident during pre-market testing or clinical trials.
- Monitoring known risks in real-world conditions: It enables manufacturers to track and manage known risks while the device is used in various environments and patient populations.
- Informing updates to risk management and clinical performance data: PMS findings may indicate the need for changes in the risk management file, clinical evaluation, or performance claims.
- Supporting transparency and communication: By analyzing PMS data, manufacturers can provide transparent reports to stakeholders such as patients, healthcare professionals, and authorities, ensuring continuous dialogue and accountability.
The proactive nature of PMS creates a feedback loop that helps in the continuous improvement of device design, labeling, and instructions for use.
CLASSIFICATIONS UNDER IVDR
PMS Requirements | Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Classification under IVDR 2017/746 | |||
| Class A | Class B | Class C | Class D | |
| PMS Plan (IVDR Art 79 and Annex III, Section 1) | Required | Required | Required | Required |
| Post-market surveillance report (PMSR) (IVDR Art 80) | Required, make available to Notified Body (NB) / Competent Authority (CA) upon request | Required, make available to NB/CA upon request | Use PSUR instead | Use PSUR instead |
| Periodic safety update report (PSUR) (IVDR Art 81) | Not Required Use PMSR instead | Not Required Use PMSR instead | Required, update at every two years Make available to CA/NB upon request | Required, update at least annually Make available to CA upon request Submit to NB |
| Post-market performance follow-up (PMPF) (IVDR Annex III, part B) | May not be required | May be required | Most likely required | Most likely required |
- CA = Competent Authority (national regulatory authority in each EU Member State)
- NB (Notified Body) = A conformity assessment body designated to perform audits and assessments under IVDR.
Class A & B Devices
For Class A and B devices, manufacturers are required to maintain and periodically review a PMS Report (PMSR). This report must be readily available to competent authorities upon request and updated when significant new information arises from post-market surveillance.
References:
- EU IVDR 2017/746, Article 80 – PMS Report Requirements for Class A and B Devices
Class C & D Devices
For Class C and D devices, manufacturers must compile and submit a PSUR at regular intervals (every two years for Class C and annually for Class D devices). This PSUR must be available to the notified body and uploaded to EUDAMED if the system is operational.
References:
- EU IVDR 2017/746, Article 81 – PSUR Requirements for Class C and D Devices
KEY REGULATORY ASPECT : IVDR REGULATIONS
Chapter VII (Articles 78–81)
Chapter VII of the EU IVDR 2017/746 outlines the legal framework for PMS:
- Article 78: Requires manufacturers to establish and maintain a comprehensive PMS system that monitors device safety and performance post-market.
Â
- Article 79: Describes the structure and content of the PMS Plan, which is device-specific and tailored according to risk classification. It includes detailed instructions on how to monitor, evaluate, and act upon post-market data.
Â
- Article 80: Mandates that manufacturers of Class A and B devices prepare PMS Reports (PMSRs) to summarize post-market findings and identify any corrective actions.
Â
- Article 81: Introduces the Periodic Safety Update Report (PSUR) requirement for Class C and D devices. These reports must be submitted at regular intervals (every two years for Class C and annually for Class D devices) and provide a comprehensive summary of the device’s safety and performance data.
Annexes III & XIII
- Annex III: This annex specifies the technical documentation that manufacturers must maintain to demonstrate compliance with PMS obligations. It requires the inclusion of the PMS Plan and outputs such as PMS Reports (PMSRs), Periodic Safety Update Reports (PSURs), and Post-Market Performance Follow-Up (PMPF) evaluation reports.
Â
- Annex XIII: Focuses on performance studies. These studies are crucial in post-market surveillance, helping gather real-world clinical evidence. The findings from these studies inform PMS activities, particularly PMPF, which ensures that long-term data and real-world performance are consistently assessed.
References:
- EU IVDR 2017/746, Annex III – Technical Documentation Requirements
Â
- EU IVDR 2017/746, Annex XIII – Performance Studies and Post-Market Follow-Up
RELATION WITH VIGILANCE AND CORRECTIVE ACTIONS
PMS is closely linked to vigilance systems and corrective actions, as follows:
- Vigilance system: As outlined in Article 82 of the IVDR, manufacturers must report incidents, risks, and safety concerns to competent authorities. If adverse events or performance failures are identified through PMS, they must be reported promptly.
- Field Safety Corrective Actions (FSCAs): PMS findings may trigger the need for Field Safety Corrective Actions, including product recalls or corrections. Trends identified through PMS analysis can lead to the initiation of Corrective and Preventive Actions (CAPAs), which may result in updates to device design, labeling, or packaging.
- The feedback and complaint handling processes outlined in Clauses 8.2.1 and 8.2.2 are intrinsically linked to vigilance activities and the implementation of corrections and corrective actions under a Quality Management System (QMS). These processes collectively ensure ongoing compliance with regulatory requirements and maintain the safety, performance, and quality of medical devices throughout their lifecycle.
- EU IVDR 2017/746, Article 82 – Vigilance Requirements
- ISO 13485:2016, Section 8.5.2 – Corrective and Preventive Actions (CAPA)
- ISO 13485:2016, Clauses 8.2.1 and 8.2.2 – Feedback and Complaint handling
POST-MARKET SURVEILLANCE (PMS) DOCUMENTATION AND REPORTING REQUIREMENTS UNDER EU IVDR
PMS Plan
Every IVD device must have a PMS Plan that clearly outlines:
- The sources of post-market data (such as complaints, incident reports, user feedback, and literature reviews).
- Methodologies for data collection and analysis.
- Performance indicators to evaluate safety and effectiveness.
- Assigned roles and responsibilities for monitoring and managing post-market data.
The PMS Plan ensures that manufacturers collect relevant data, analyze it appropriately, and respond in a timely manner to any safety or performance concerns.
References:
- EU IVDR 2017/746, Article 79 – PMS Plan Requirements
INTEGRATION WITH QMS & RISK MANAGEMENT
ISO 13485 / 14971 Linkage
Post-market surveillance activities must align with the manufacturer’s Quality Management System (QMS) and Risk Management (RM) procedures. Key standards include:
- ISO 13485: Defines the QMS requirements for medical devices, including processes to monitor and analyze post-market data, ensure continuous quality improvement, and meet regulatory standards.
- ISO 14971: Provides guidelines for managing risks associated with medical devices. PMS data feeds directly into the risk management file, helping identify new risks or modifications required to reduce patient harm.
CAPA Integration and Change Control
If PMS data uncovers risks or performance issues, the manufacturer may need to initiate:
- Corrective Actions (CAPA): To correct identified problems (e.g., device malfunction, safety issues).
- Preventive Actions: To prevent recurrence of these issues.
These actions are integrated into the QMS to ensure change control and continuous improvement. The updates to technical documentation, device design, and labeling may also be necessary.
References:
- ISO 13485:2016 – Medical Devices: Quality Management Systems
- ISO 14971:2019 – Application of Risk Management to Medical Devices
- EU IVDR 2017/746, Article 10 – General Requirements for QMS
PMS FOR LEGACY DEVICES
Transitional Provisions
For legacy devices that were on the market before the IVDR became effective, manufacturers must ensure they still comply with the PMS requirements under the new regulation. The IVDR provides transitional provisions that allow manufacturers to continue marketing these devices but requires them to update their technical documentation to reflect PMS data, ensuring they meet the current safety standards.
References:
- EU IVDR 2017/746, Article 110 – Transitional Provisions for Legacy Devices
PRACTICAL STEPS TO IMPLEMENT PMS
Gap Assessment to Internal Audits
To implement a robust PMS system, manufacturers must follow these practical steps:
- Gap Assessment: Review current PMS processes and compare them to the requirements of the IVDR to identify areas for improvement.
- Internal Audits: Regularly audit PMS activities to ensure that the process is functioning as intended and compliant with IVDR. Audits should evaluate data collection methods, reporting processes, and the effectiveness of CAPA measures.
References:
- EU IVDR 2017/746, Articles 82 to 83 – PMS System and Reporting Obligations
- ISO 13485:2016Â
- Manufacturers should begin with a gap assessment (Clauses 4.1.2, 4.2.1, 8.2.1, 8.2.2) to compare their existing PMS practices against regulatory requirements and identify areas for improvement.Â
- This should be followed by internal audits (Clauses 8.2.4, 8.5.1) to verify that the PMS process is functioning as intended, especially regarding data collection, reporting, and CAPA effectiveness.
CHALLENGES & BEST PRACTICES
Data Volume, Resource Use, Benchmarking
Challenges in PMS implementation include:
- Data volume: Managing and analyzing large datasets from multiple sources can be overwhelming.
- Resource Allocation: Implementing a PMS system requires dedicated resources, including staff, technology, and financial investment.
- Benchmarking: Establishing benchmarks for device performance, especially for novel or complex devices, can be difficult, as there may be limited historical data for comparison.
Best Practices:
- Centralized data management: Using digital tools or platforms to streamline data collection and analysis.
- Regular training: Ensuring personnel are trained in PMS procedures and regulatory requirements.
- Clear communication channels: Establishing a clear process for escalating issues identified through PMS.
CONCLUSION
Post-market surveillance is an essential regulatory requirement under the EU IVDR 2017/746. By integrating PMS with risk management and quality systems, manufacturers can ensure their devices continue to meet safety and performance expectations. The best practices, alongside the guidelines provided by MDCG, ensure that PMS systems remain compliant and effective throughout a device’s lifecycle.
HOW WE CAN HELP
In Morulaa supports IVD manufacturers in effectively implementing and maintaining Post-Market Surveillance (PMS) systems as required under EU IVDR 2017/746. We help ensure full compliance with Articles 78 to 81, covering the development of PMS Plans, PMS Reports (PMSRs), Periodic Safety Update Reports (PSURs), and Post-Market Performance Follow-Up (PMPF) protocols, tailored to the device’s classification (Class A to D). Our expertise includes performing gap assessments against IVDR and ISO 13485/14971 standards, setting up PMS data collection strategies from both reactive and proactive sources, aligning PMS outputs with risk management systems, and integrating corrective and preventive actions (CAPA) into the quality management framework.