Summary
Eclevar MedTech can assist manufacturers to comply with post-market surveillance requirements for medical devices. The manufacturer should establish and maintain a system that gathers, records, and analyses relevant data on the quality, performance, and safety of the device to detect any necessary corrective or preventive actions.
The post-market surveillance system should be part of the quality management system and should have a plan, including protocols to manage events subject to trend reports. The manufacturer should report to competent authorities any serious incident or field safety corrective action. Technical documentation should be updated accordingly.
Manufacturers must prepare and update post-market surveillance and periodic safety reports for competent authorities. Checks on device conformity and performance are based on risk management principles, using Eudamed and vigilance reporting systems. Clinical investigation rules must align with international guidance to ensure device safety and public health.
How can Eclevar MedTech support clients in achieving compliance with Post Market Surveillance requirements?
Eclevar MedTech can help medical device manufacturers fulfil their responsibilities during the post-market phase by assisting them in systematically collecting and analysing information about the performance of their devices, updating their technical documentation, and collaborating with the relevant national competent authorities responsible for vigilance and market surveillance This proactive approach, known as “post-market surveillance,” involves ongoing efforts by manufacturers to monitor the safety and effectiveness of their products and take corrective or preventive actions as needed.
What should manufacturers do to achieve compliance?
In order to achieve this goal, manufacturers need to establish a comprehensive post-market surveillance system that is integrated into their overall quality management system and is guided by a detailed post-market surveillance plan.
This plan should be included as a component of the technical documentation and serve as the foundation for the post-market surveillance system.
What activities shall the post market surveillance system identify?
Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system.
2. The post-market surveillance system shall be suited to actively and systematically gathering, recording, and analysing relevant data on the quality, performance, and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
3. Data gathered by the manufacturer’s post-market surveillance system shall in particular be used:
- to update the benefit-risk determination and to improve the risk management.
- to update the design and manufacturing information, the instructions for use and the labelling
- to update the clinical evaluation
- to update the summary of safety and clinical performance
- for the identification of needs for preventive, corrective, or field safety corrective action
- for the identification of options to improve the usability, performance, & safety of the device.
- when relevant, to contribute to the post-market surveillance of other devices; and
- to detect and report trends.
The technical documentation shall be updated accordingly.
The technical documentation on post-market surveillance drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described:
- The post-market surveillance plan drawn up.
- The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in the EU MDR
- Post-market surveillance plan shall address the collection & utilisation of available information.
- Information concerning serious incidents, including information from PSURs, and field safety corrective actions.
- Records referring to non-serious incidents and data on any undesirable side-effects.
- Information from trend reporting
- Relevant specialist or technical literature, databases and/or registers
- Information, including feedbacks and complaints, provided by users, distributors and importers, and publicly available information about similar medical devices.
The post-market surveillance plan shall cover at least.
- a proactive & systematic process to collect any information referred to in point The process shall allow a correct characterisation of performance of the devices & shall also allow a comparison to be made between device & similar products available on the market.
- effective and appropriate methods and processes to assess the collected data.
- suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management.
- effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field.
- methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period.
- methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators, and users.
- reference to procedures to fulfil the manufacturers obligations.
- systematic processes to identify & initiate appropriate measures including corrective actions.
Vigilance
Reporting of serious incidents and field safety corrective actions
1. Manufacturers of devices made available on the Union market, shall report, to the relevant competent authorities, the following:
Ø any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting.
Ø any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
Ø The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user.
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market.
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
Post-Market Clinical Follow-Up
PMCF shall be understood to be a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post-market surveillance plan.
When conducting PMCF, the manufacturer shall proactively collect & evaluate clinical data from the use in or on humans of a device which bears the CE marking & is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure,
– with the aim of confirming the safety & performance throughout the expected lifetime of device, – of ensuring the continued acceptability of identified risks & – of detecting emerging risks on the basis of factual evidence.
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
- confirming the safety and performance of the device throughout its expected lifetime
- identifying previously unknown side-effects & monitoring the identified side-effects & contraindications
- identifying and analysing emergent risks on the basis of factual evidence
- ensuring the continued acceptability of the benefit-risk ratio and
- identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
The PMCF plan shall include at least:
a) General methods & processes of PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature & other sources of clinical data.
b) the specific methods & processes of PMCF to be applied, such as evaluation of suitable registers or PMCF studies.
c) a rationale for the appropriateness of the methods and procedures
d) a reference to the relevant parts of the clinical evaluation report and to the risk management.
e) the specific objectives to be addressed by the PMCF.
f) an evaluation of the clinical data relating to equivalent or similar devices
g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
h) a detailed and adequately justified time schedule for PMCF activities (e.g., analysis of PMCF data and reporting) to be undertaken by the manufacturer.
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation and in the risk management. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
What documentation/records shall post market surveillance system produce?
Post-market surveillance report
Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results & conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale & description of any preventive & corrective actions taken. The report shall be updated when necessary & made available to the competent authority upon request.
If you’re a manufacturer of class I medical devices, it’s important to take note of the requirement to prepare a post-market surveillance report. This report should summarize the results and conclusions of the analyses that have been conducted using the data gathered from your post-market surveillance plan. In addition to this, you should also include a rationale and description of any corrective or preventive actions that have been taken as a result of these analyses.
It’s worth noting that this report should be updated on a regular basis, as and when necessary. And it’s important to keep in mind that the competent authority may request this report from you at any time, so it’s essential that you keep it up to date and ensure that it accurately reflects your post-market surveillance activities.
Periodic safety update report
Manufacturers shall prepare a periodic safety update report (‘PSUR’) for each device & where relevant for each category or group of devices summarising the results & conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
- the conclusions of the benefit-risk determination
- the main findings of the PMCF; and
- the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device
Manufacturers shall update the PSUR at least annually. That PSUR shall be part of the technical documentation.
Manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
In the medical device industry, it’s essential to ensure that devices are safe and effective for use. Competent authorities play a crucial role in this process by performing appropriate checks on the conformity characteristics and performance of devices. These checks can involve reviewing documentation and conducting physical checks on samples.
To ensure that risk assessment and management principles are taken into account, competent authorities also consider vigilance data and complaints. The Eudamed electronic system serves as a helpful tool for reporting serious adverse events, device deficiencies, and related updates during clinical investigations.
Another essential electronic system in the industry is the one dedicated to vigilance reporting. Manufacturers can use this system to report serious incidents and other reportable events, which can then be evaluated by competent authorities.
