Significant changes have been introduced to the regulatory landscape, specifically to post-market surveillance for medical devices (PMS) through the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
After the introduction of these regulations, it has become mandatory for medical device and IVD manufacturers to adhere to them. The ultimate goal is to maintain the high level of safety and performance of devices in the European Union market.
Key points we are going to discuss in this article:
⦿ What is Post-market surveillance for medical devices?
⦿ What is a post-market surveillance plan (PMSP) for Medical Devices?
⦿ What is a post-market surveillance plan (PMSP) for IVDs?
⦿ Sources of PMS Data
⦿ What is the impact of Post Market Surveillance on the Medical Device Clinical Evaluation?
What is Post-market surveillance for medical devices?
Post-market surveillance (PMS) is an ongoing process that allows medical device and IVD manufacturers to continuously collect and analyze data related to the quality, safety, and performance of their devices throughout their lifecycle.
This process is essential for detecting any issues that may require immediate corrective or preventive action (CAPA).
Both MDR and IVDR mandate the establishment of a PMS management system tailored to the device’s risk class and type, ensuring a systematic approach to post-market data collection and analysis.
Role of Medical Device & IVDR post-market surveillance Data
Article 83 of the MDR and Article 78 of the IVDR outline the critical role of post-market surveillance (PMS) data, emphasizing its importance for several key functions:
1. Risk Management and Assessment:
PMS data must be used to update the risk-benefit assessment and enhance risk management practices, as outlined in Annex I, Chapter I of Article 83 of the MDR & Article 78 of the IVDR.
2. Design and Labeling Updates:
The information gathered during the post-market surveillance of medical devices should be utilized to refine the device’s design, manufacturing processes, instructions for use, and labeling
3. Clinical and Performance Evaluation:
PMS data is crucial for revising the clinical evaluation of medical devices or the performance evaluation of IVDs.
4. Safety Summaries:
The data collected during the PMS process should be used to update the summary of safety and clinical performance (for medical devices) or performance (for IVDs), as required by Article 32 of the MDR and Article 29 of the IVDR
5. Corrective Actions:
Identifying the need for preventive, corrective, and safety-related actions is a key use of PMS data.
6. Device Improvement:
The data should help pinpoint opportunities to enhance the usability, performance, and safety of the device.
7. Cross-Device Surveillance:
PMS data also contributes to the surveillance of other devices when relevant.
8. Trend Identification:
Lastly, PMS data should be utilized to detect and report trends as specified in Article 88 of the MDR and Article 83 of the IVDR.
What is a post-market surveillance plan (PMSP) for Medical Devices?
The post-market surveillance (PMS) system is anchored by a post-market surveillance plan (PMSP), which outlines the specific activities, timelines, and evaluation criteria to be followed.
This plan also includes provisions for post-market clinical follow-up (PMCF), detailing the procedures and methods for gathering performance data as required by Articles 84 (MDR) and 79 (IVDR).
PMSP For Class I Medical devices
For Class I medical devices, when it comes to a post-market surveillance plan (PMSP), the report must contain the following:
⦿ The data collected through the PMS process
⦿ Evaluate potential risks
⦿ Detail any corrective and preventive actions taken
PMSP For Class IIa, IIb, and III Medical devices
For Class IIa, IIb, and III medical devices, the requirements are more stringent. These devices must have a periodic safety update report (PSUR), which must be updated at least every two years for Class IIa devices and annually for Class IIb and III devices.
According to Article 86 of the MDR, the PSUR should include:
⦿ Risk-Benefit Conclusions: Findings relevant to the ongoing risk-benefit assessment.
⦿ PMCF Findings: Key insights from the post-market clinical follow-up.
⦿ Usage Data: Information on the sales volume, an estimate of the size and characteristics of the user population, and, where possible, the frequency of use.
What is a post-market surveillance plan (PMSP) for IVD?
For in vitro diagnostic devices (IVD), the requirements mirror those for medical devices with some variations.
Class A and B devices require a PMSR, updated as necessary and available to the competent authority upon request, as stated in Article 80 of the IVDR.
For Class C and D devices, a PSUR must be prepared and updated annually in compliance with Article 81 of the IVDR.
Sources of PMS Data
As per the standard, “ISO/TR 20416:2020 Medical devices – Post-market surveillance for medical device manufacturers need to outline several proactive methods for data collection, including:
⦿ Written or electronic questionnaires
⦿ User interviews
⦿ Literature research
⦿ Use of registries
⦿ Post-market clinical follow-up (PMCF) studies
⦿ Information provided by regulatory agencies
Questionnaires are considered one of the efficient ways to gather extensive clinical data from a large number of patients or users (post-market surveillance data). Another highlight of using questionnaires is that they are relatively easy to deploy, quick to administer, and cost-effective compared to more resource-intensive methods like post-market clinical investigations.
Additionally, questionnaires can be fully tailored to the specific device and customized to meet the sponsor’s unique requirements.
For ensuring the quality and reliability of the PMS data, it is mandatory that questionnaires must be used correctly.
The ISO/TR 20416:2020 standard provides guidelines emphasizing that questionnaires should be:
⦿ Designed to be clear and easy to complete
⦿ Validated to accurately measure the intended aspects
⦿ Distributed to a representative sample of the target population
What is the impact of Post Market Surveillance on the Medical Device Clinical Evaluation?
The new regulations have improved the standards for collecting clinical data and evidence, placing greater focus on the clinical evaluation or performance evaluation processes to ensure compliance with the General Safety and Performance Requirements (GSPR).
This includes integrating post-market surveillance data into the clinical or performance evaluation.
Under the MDR, post-market surveillance information, particularly from post-market clinical follow-up (PMCF), is classified as “clinical data” according to Article 2.
This data can be used to update key aspects of the technical documentation, such as risk assessments, benefit-risk evaluations, and clinical evaluations.
Additionally, the MDCG 2020-6 guideline titled ‘Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC – A guide for manufacturers and notified bodies’ outlines a harmonized approach to using clinical data for legacy devices that require recertification under the MDR.
The guideline emphasizes that clinical data obtained from medical devices and IVDR Post-market surveillance (PMS), especially PMCF data, should be incorporated into the clinical evaluation process.
Therefore, the clinical evaluation plan must include strategies and methods for systematically collecting, summarizing, and analyzing PMS data to demonstrate the continued safety and performance of the device and to support the acceptability of its benefit-risk profile.
Bottom Line
The PMS requirements introduced by the MDR and IVDR mark a substantial difference w.r.t to the earlier regulations.
These new, more rigorous standards mandate that manufacturers proactively gather and analyze comprehensive data on the safety and performance of their medical devices and IVDs.
The goal of these enhanced requirements is to ensure that medical devices and in vitro diagnostic devices available in the EU market remain safe and effective for patients and users not just when they are launched but also throughout their lifecycle.
In case you are looking to build a fully-functional and efficient post-market surveillance system and plan for your medical device or IVD, you can contact us at connect@elexes.com or fill out this form, and we will get back to you asap.
