Post Market Surveillance (PMS) under IVDR 2017/746
EU IVDR 2017/746 Post Market Surveillance (PMS) Guide
Post Market Surveillance (PMS) is far from being a new phenomenon for the producers of in vitro diagnostic (IVD) devices. The previous directive, IVDD (98/79/EC), has already addressed the need to have a mechanism for monitoring and evaluating the performance of a device following its placing on the market. In particular, Annex III, Section 5 of IVDD stressed the necessity to gather and analyze the post production data to make sure the device remains safe and effective. Moreover, the ideas of PMS have been backed by some international standards, such as ISO 13485, which provides the guidelines on the requirements for the quality management system for medical devices, and ISO 14971, which deals with the risk management process throughout the lifecycle of a device. Nevertheless, the introduction of IVDR (2017/746) marks the shift towards more stringent PMS.
Why PMS Is Important Under IVDR
As per the EU IVDR 2017/746, Post Market Surveillance (PMS) is a compulsory regulation that seeks to monitor the safety and performance of in vitro diagnostic (IVD) devices when already on the market. There are a number of reasons why PMS is important, which include:
Identification of new risks that were not identified earlier: In PMS, new safety risks or performance risks that could not be detected during pre-market testing or in clinical studies are identified.
Monitoring of known risks in real life setting: It allows manufacturers to monitor known risks when in vitro devices are being used in different settings and on different patients.
Updating risk management and performance information: From the results of PMS, it might become necessary to update risk management files and clinical evaluation/performance.
Facilitating transparency and communication: By analyzing PMS information, it is possible for manufacturers to provide transparency and information to all stakeholders like patients, health professionals, and authorities.
The proactive aspect of PMS leads to a feedback loop for continuous improvement of device design, labeling, and instructions for use.
Classifications Under IVDR
PMS Requirements | 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
| 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
|
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, it is mandatory for the manufacturer to keep an updated and reviewed PMS Report (PMSR). It should be accessible to the competent authority if requested and it should be updated with any significant findings related to 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, it is mandatory for the manufacturer to produce and submit PSURs on regular intervals (every two years for class C and every year for class D devices). It should be available to the notified body and uploaded on EUDAMED in case it 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)
Article 78 states the requirements for establishment of a well developed PMS in relation to medical device monitoring in the post market stage:
Article 78: Specifies that manufacturers shall put into place a well developed PMS System for post market monitoring of device safety and performance.
Article 79: Describes the structure and content of the PMS Plan that is device specific and tailored according to the risk category of the product. It provides detailed instructions concerning monitoring, evaluation, and action taken as per the post market data.
Article 80: States the obligation for manufacturers of Class A and B devices to develop PMS Reports (PMSRs) summarizing the post market results and taking any actions.
Article 81: States the requirement for the development of a Periodic Safety Update Report (PSUR) for Class C and D devices on a regular basis (biannually for Class C and annually for Class D devices).
Annexes III & XIII
Annex III: It outlines the technical documents that need to be created by manufacturers in order to fulfill their PMS obligations. The PMS Plan along with outputs like PMS Reports (PMSRs), PSURs, and PMPF evaluation reports are some of the documents included here.
Annex XIII: It concentrates on performance studies. They play an important role in post market surveillance because they provide real world data. The results of the studies will be used for PMS activities, especially the PMPF process, which provides continuous long term data.
References:
EU IVDR 2017/746, Annex III: Technical Documentation Requirements
U IVDR 2017/746, Annex XIII: Performance Studies and Post Market Follow Up
Relation With Vigilance And Corrective Actions
PMS has a direct correlation with vigilance systems and corrections/corrective actions, specifically:
Vigilance system: According to Article 82 of the IVDR, manufacturers are obliged to notify competent authorities about incidents, risks, and safety issues. Should any adverse events or malperformances of products be detected via PMS, then such events should be reported without delay.
Field Safety Corrective Actions (FSCAs): PMS results can also give rise to FSCAs, including recalls or corrections of a medical device. Trends revealed during PMS analysis could also result in initiating Corrective and Preventive Actions (CAPAs), which can include changes in design, labelling, or packaging of the device.
Feedbacks and complaints described in clauses 8.2.1 and 8.2.2 are directly related to vigilance activities and corrections/corrective actions carried out within a QMS.
EU IVDR 2017/746, Article 82 - Vigilance Requirements
ISO 13485:2016, Section 8.5.2 - Corrective and Preventive Actions (CAPA)
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
Each IVD device shall have a PMS Plan that provides information on the following:
Sources of post market information (e.g. complaints, incident reports, user comments, literature search)
Methods for data gathering and analysis.
Performance parameters for assessing the safety and efficacy.
Responsibilities of individuals involved in the post market data process.
This plan ensures that manufacturers gather the right data, conduct a proper analysis, and make an adequate response when necessary.
References:
EU IVDR 2017/746, Article 79 – PMS Plan Requirements
Sources Of Post Market Data
Reactive and Proactive Sources (Annex III, 1(d), 1(f); Article 82) Reactive sources:
These are founded on incidents or event reports and response procedures.
Serious Incidents and Field Safety Correction Actions (FSCAs).
Non Serious Incidents.
User or Healthcare Professional Complaints.
Notifications made by Competent Authorities.
Market Withdrawal/Recall of products because of safety/performance problems.
Incident/Event reports identified via customer service/technical support.
Proactive sources:
Article 2 (63) - post market surveillance means 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.
Annex III 1(b) - The post market surveillance plan shall cover at least: a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market.
References:
EU IVDR 2017/746, Annex III (section A and B) and Article 82 – Vigilance and Field Safety Corrective Actions
Integration With QMS & Risk Management
ISO 13485 / 14971 Linkage
PMS should be conducted according to the requirements of the QMS and RM systems of the medical device manufacturer. The most important standards related to this activity are:
ISO 13485: Establishes the requirements for the QMS of medical devices and contains the procedures for monitoring and analyzing the post market data, continuous quality improvement, and compliance with regulatory requirements.
ISO 14971: Gives recommendations on how to manage risks in relation to medical devices. Information obtained during PMS is immediately used to update the risk management file.
CAPA Integration And Change Control
If risks and performance problems are detected through PMS, the manufacturer might be required to conduct:
Corrective Actions (CAPA): For correcting the identified problem (e.g., malfunction, safety problem).
Preventive Actions: For preventing the recurrence of these problems.
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 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
As far as legacy devices released prior to the coming into effect of the IVDR, it is important for the manufactures of such devices to ensure that these devices still conform to the requirements of PMS. IVDR offers transition measures allowing manufacturers to sell their devices without making changes in technical documentation reflecting PMS data.
References:
EU IVDR 2017/746, Article 110 – Transitional Provisions for Legacy Devices
Practical Steps To Implement PMS
Gap Assessment to Internal Audits
For a successful implementation of the PMS system, the following steps should be followed by manufacturers:
Gap Analysis: Analyze existing PMS systems and check their compatibility with the IVDR.
Internal Audits: Carry out regular audits of PMS activities to check whether the process is working in the right way according to IVDR. These audits will assess the methods of collecting data and the efficiency of CAPA measures.
References:
EU IVDR 2017/746, Articles 82 to 83 - PMS System and Reporting Obligations
ISO 13485:2016
1. The manufacturer should start with an audit of the current gap (Clauses 4.1.2, 4.2.1, 8.2.1, 8.2.2) to evaluate the manufacturer’s current practices in relation to the regulatory guidelines and the possible areas of improvement.
2. This should be done after conducting the internal audit (Clauses 8.2.4, 8.5.1) in order to ensure that the process of PMS works properly.
Challenges & Best Practices
Data Volume, Resource Use, Benchmarking
Challenges in PMS implementation include:
Volume of Data: Managing and analyzing large amounts of data from different sources can be challenging.
Resource Allocation: There is a need for allocation of resources to implement PMS.
Benchmarking: It can be challenging to set performance benchmarks for devices due to limited historical data.
Best Practices:
Data management in a centralized manner: By using technology based tools for the collection and analysis of data.
Training programs: The need to train the staff members regarding the PMS processes.
Channel of communication: Having a channel of communication to report any findings by the PMS.
Conclusion
Post market surveillance is an obligatory part of regulation according to the IVDR 2017/746 by the EU. With the implementation of post market surveillance in conjunction with risk management and quality management, it becomes possible for manufacturers to make sure that their devices are still compliant and safe. Best practices, as well as guidelines of the MDCG, help with compliance of PMS.
How We Can Help
Morulaa assists in the implementation and management of the PMS system for IVD manufacturers in accordance with the EU IVDR 2017/746 regulation requirements. We assist you in complying fully with Articles 78 through 81 related to development of PMS plans, PMS reports (PMSRs), periodic safety update reports (PSUR), and post market performance follow up (PMPF) procedures, depending on the class of the device (Class A to D). Morulaa can assist you with conducting gap analysis based on IVDR and ISO 13485/14971 requirements, development of PMS data gathering approaches both proactive and reactive, alignment of PMS outputs with risk management systems, and incorporation of CAPA into the QMS.
Other posts
Don't let European red tape stall your vision. We simplify complex EU building regulations so you can focus on creation. Explore our blog for the clarity you need during your project and the insights required for post completion compliance. Read on for smoother approvals and smarter builds across Europe.