EU MDR Post Market Surveillance
EU MDR Post Market Surveillance is necessary and an obligation of the manufactures regardless for the medical device’s classification. The conformity assessment processes for acquiring a CE mark, as defined in Annexes IX to XI, require that manufacturers create and maintain a PMS mechanism proportional to the device’s risk class and type, but only the requirements change as per the risk class.
Medical device manufacturers must base their PMS system on a post market surveillance plan (Article 84), which must be included in the technical documentation and must demonstrate compliance with the 2017/745 PMS criteria. Annex III lays out the standards and substance of a PMS strategy, which must address the collection and use of post-market data.
Article 2, section 60 of MDR defines PMS as a proactive and systematic process that manufacturers implement and carry out with other economic operators such as importers, distributors, authorized representatives etc.; in order to take corrective and preventive action (CAPA) in accordance with the information on medical device and their performance.
The PMS and Reporting of incidents involving medical devices allow identification of problems with the design, manufacture or use of medical devices and, ultimately, enhances patient safety. The aim of the PMS System is to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire medical device lifetime.
This allows manufacturers to continuously update the risk-benefit assessment and to initiate necessary measures without delay. Manufacturers are obliged to collect and assess all information about their medical device and related devices from competitors.
Class I medical devices manufacturers (including classes Is, Im, and Ir) are obliged to provide a PMS Report that summarizes the outcomes and conclusions of the data obtained as stated in the PMS plan. The report must include the reason for the actions taken as well as a summary of the preventative and remedial measures implemented, and it must be updated as needed.
The PMS Report or the PMSR has a record of all the PMS activities conducted as per the PMS Plan.
Medical Device manufacturers must form a cross-functional PMS team that will collaborate with other departments and the regulatory team to analyze methods and design a Post market surveillance plan. Manufacturers may more easily identify the target demographic and anticipate hazards with the aid of consultants and regulatory specialists like I3CGlobal. In the same way, when a new technology is brought to the market, an efficient monitoring program must be created to ensure the early identification of issues.
- Guides manufacturers in conducting the PMS
- Supports in drawing up the PMS plan;
- Guides in conducting the PMS activities;
- Provides well-structured PMS plan, procedure, and report templates;
- Identifies PMCF requirements from PMS data;
- Analyzes the Post Market Surveillance Data and drawing suitable conclusions.
Post Market Surveillance For Medical Device
While developing a PMS , it is essential to evaluate the product technology in connection to the manufacturer and the marketplace of similar devices. There may be a lack of awareness of the patient population and the complexity of the device state among new technology makers.
PMS Requirements For Medical Devices
The scope and goal of PMS within the European Union are meticulously spelled forth in (Definition 60) Article 2 of the EU Medical Devices Regulation (MDR 2017/745), since the regulations applicable to medical devices have changed and grown substantially.
- Current market data for similar devices may be adequate to meet clinical assessment requirements for low-risk devices with a long history of usage.
- Appropriate and quantifiable clinical data on the device’s safety and performance from peer-reviewed literature to support the clinical evaluation criteria.
- Increased monitoring to guarantee the early detection of hazards that were not anticipated during the development process.
- Post-market clinical follow-up (PMCF) may be necessary to collect adequate real-world clinical use of the technology.
- A thorough and proactive strategy to obtaining the data is indicated in point (a). The method must allow for reliable evaluation of the device’s performance as well as comparisons with similar goods on the market.
- Methods and processes for assessing the data collected that are efficient and appropriate;
- Suitable indicators and threshold values for use in the continuous evaluation of the benefit-risk analysis and risk management described in Annex I Section 3;
- Techniques and protocols for managing the events mentioned in Article 88’s trend report, including techniques and processes for identifying any statistically significant increase in the frequency or severity of occurrences, as well as the observation period;
- Techniques and protocols for communicating with competent authorities, notified bodies, business operators, and user
- A description of the procedures for carrying out the manufacturer’s obligations under Articles 83, 84, and 86.
- Processes for identifying and putting in place appropriate measures, such as corrective actions;
- Effective methods for tracing and detecting devices that might need to be repaired;
- and a PMCF plan, as specified in Annex XIV Part B, or a reason for why a PMCF is not necessary.
With the arrival of MDR compared MDD found more clarity in the PMS requirements against requirements of ISO 14971 clause 9. MDR, which defines Post Market Surveillance as one of the general duties of all device manufacturers as per Article 2 (60). MDR has also explicitly requested employees in charge of monitoring and verifying regulatory compliance. In compliance with EU MDR, manufacturers must now proactively upgrade their PMS system in a complete and methodical manner.
This enables manufacturers to implement an interactive corrective action or preventative action approach appropriate for the device type, as well as update clinical assessment documentation. It’s crucial to remember that PMS requirements should be proportional to the danger posed by the item depending on its intended usage.
PMS & ISO 13485 Relationship
The Post Market Surveillance should be integrated into the company’s Quality Management System (ISO 13485) and should be built together to analyze the data on quality, performance, and safety of the device throughout its entire lifecycle. It should also be allowed to draw conclusions about this data and be linked to the company’s preventive and corrective action system.
PMS could be ‘Reactive’ – responding after an event has occurred and is considered passive as they are largely data collection activities.
PMS could be ‘Proactive’ – endeavors meant to anticipate and curtail events before they occur and are considered active as they give insights and data into the real-world performance of the device
|PMCF or other post CE clinical trials|
|Expert user groups|
Post Market Surveillance, like the ISO 14971 clause 9 requirement for post-production monitoring, should be commensurate to the risk associated with the device based on its intended usage. The lack of clarity has since been remedied with MDR, which defines PMS as one of the general duties of all producers in Article 2 (60).
Additionally, MDR has specifically called out manufacturers required to update their PMS system proactively in a comprehensive and systematic fashion in accordance with EU MDR by the personnel responsible for monitoring ensuring regulatory compliance (PRRC). This allows the manufacturers to set in place an interactive corrective action or preventive action process which is proportionate to the device type and update clinical evaluation documents.
MDR has also expressly stated that manufacturers must update their PMS system proactively in a thorough and systematic manner in line with EU MDR by people responsible for monitoring and maintaining regulatory compliance (PRRC). This enables manufacturers to implement an interactive corrective action or preventative action approach appropriate for the device type, as well as update clinical assessment documentation.
It’s crucial to remember that PMS requirements should be proportional to the danger posed by the item depending on its intended usage.
Because ISO 13485 applies to all medical devices on the market, PMS strategies must be developed in conjunction with a proactive Post Market Surveillance. Because vigilance is a QMS output, it’s useful to arrange post-market clinical data collection efforts within a device’s technical documentation.
As a result, creating a medical device vigilance system in the post-production phase to report significant device-related occurrences to authorities might help to discover previously unreported adverse product information. This evaluation may be beneficial in preventing future occurrences of situations that may have resulted in death or significant health deterioration.
The PMS system of medical device referred to in article 83 is based on a post market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. This PMS plan outlines the actions associated with device specific post market monitoring. The procedure for PMS describes in detail how to conduct it.
Frequently Asked Questions
Vigilance System in PMS
Vigilance is a result of a well implemented ISO 13485 system, and it is thus advantageous to plan post-market clinical data collection activities during the technical documentation of a device. As a result, implementing a vigilance system in the post-production phase to report major device-related occurrences to authorities might significantly aid in the discovery of previously undisclosed unfavorable product information. This assessment can help to prevent the recurrence of occurrences that could have resulted in death or major health deterioration in the future.
Why constant monitoring of medical device post market surveillance?
Constant monitoring of the device allows for early detection of hazards and production issues. It allows for the early detection of related hazards and gives the manufacturer with early feedback on device use in a real-time environment, allowing for the maintenance of good product quality. This benefits both the manufacturer and the patient.
Can I modify MEDDEV 2.7/1 Rev 3 documents to MDR Article 61 directly.
MEDDEV 2.7/1 Rev 3 & 4 is only a guidance document. Manufactures must complete documentation in line with MDR Article 61 for easy NB approval.
How can I verify Medical Device Clinical Evaluation documents are correct?
We offer a FREE tool made in line with the latest MDR. Customers can browse the page and take a trial to find the GAPS.
Is Post Market Surveillance is part of the CER documentation?
Yes, Post Market Surveillance, Post Market Clinical Follow Up and Periodic Safety Update Report are part of new MDR and essential for CER documentation.