The field of medical device regulation is vast and varied, which highlights the importance placed on ensuring that this functions effectively.
This essay looks at a few touchpoints between the different aspects of medical device regulation – clinical evaluation, post-market surveillance (PMS), PMCF and PSURs.
Comprehension about how these components interact is crucial for manufacturers, regulators and healthcare providers within the public health sector to sustain and improve access.
Medical Device Regulation
Medical device regulation is the set of rules by which governments oversee that medical devices work as intended and are safe for use. Regulatory agencies are here: FDA (United States) and EMA (Europe) The Medical Device Regulation (MDR) 2017/745 has significantly altered the regulatory environment in Europe, with a clear emphasis on lifecycle and safety/performance.
The MDR sets out stringent pre-market and post-market obligations, focusing on clinical evidence and includes a more thorough process of continuous monitoring. These regulations help to minimize risk, deliver high levels of quality and safety and increase transparency with the lifecycle management for a device.
Clinical Evaluation
Evaluation of clinical performance by a third party is an essential process in the development and authorization to market new medical devices. This includes evaluation and analysis of the clinical data to demonstrate that the device is safe & performs as intended.
One requirement per Meddev 2.7.1 Rev 4 and MDR Article 61 is that this process should be comprehensive, systematic, performed by fully qualified staff members etc
Clinical evaluation is split into several different stages such as initial clinical investigation, literature review and equivalence with existing devices. This report requires all the findings to be aggregated in one place and helps demonstrate that the device ensures its safety and performance requirements.
The CER represents a living document and will be updated regularly based on new clinical data, adverse events or changes in the clinical practice.
Post Marketing Surveillance (PMS)
Post market surveillance is a continuous process for the organized scrutiny of evidence to make timely decisions required by regulatory authorities, regarding marketed medical devices. PMS: To find potential safety problems, better understand how devices work in real-world use and be available to address any issues that come up.
This PMS system must be bespoke to the device risk class and complexity defined by manufacturers in all cases according to MDR. For example, such a system should have mechanisms for the reporting of adverse events and monitoring device performance as well as oversight to monitor regulatory compliance. PMS activities contribute to the ongoing improvement of the device through informing updates to CERs and other regulatory documents with data sets collected.
The EU Regulatory Process: Post-Market Follow-Up (PMF) in the Clinical Setting
Post-market clinical follow-up is specifically designed to gather data concerning the performance and safety of a device during its entire lifetime in real-life conditions; Essentially, PMCF activities are intended to eliminate the residual risks identified in pre-market and achieve long-term performance data.
PMCF may encompass activities such as observational studies, registries and surveys. It is also necessary to check how the device will behave in real life over time, what risks are not previously known and whether or not we continue to receive the expected benefits from it. PMCF activities are used to update the CER, and thus ensure regulatory compliance.
Periodic Safety Update Reports (PSURs)
Summary of Safety and Clinical Performance is one part of obtaining the CE-Marking under MDR. The other required documents periodically for demonstrating that Periodic Safety Update Reports need to be submitted at specific intervals (related to the risk class of a device), using the data from PMS and PMCF.
The PSUR compiles safety data related to adverse events, trends and results from clinical studies providing an overall snapshot of the device’s profile. This also features a risk-benefit analysis and mentions any new risks or changes in the functioning of the device. For regulatory authorities to continue monitoring the safety of medical devices, and take interactions as needed, periodic PSURs are important.
Nexus and Significance
This almost seamless interface of medical device clinical evaluation, PMS & PSUR that has been succinctly defined in regulation will form a strong cushion to ensure safety and efficacy before CE Certification.
The clinical evaluation establishes the basis of performance assessment, with PMS and PMCF providing ongoing surveillance and data gathering across their lifecycle. PSURs consolidate this information so that regulatory authorities and manufacturers see a complete picture of the safety profile of any device.
The intertwining nature of these processes demonstrates the need for active and comprehensive medical device oversight. Identification and mitigation of potential or actual risks is a bullseye in the light of all requirements for an adequate evaluation, and continuous surveillance consisting of well-prepared PSURs. Such an integrated approach not only will ensure the necessary level of compliance with regulatory standards but also help to increase innovation and trust in medical devices.
The amalgamation of medical device regulation with clinical evaluation, PMS, PMCF and PSURs is essentially the foundation for an effective safety & performance monitoring system.
When these processes are thoroughly understood and deployed by all stakeholders, the safety, efficacy and reliability of medical devices can be improved – leading to faster Notified Body approval and CE Certification. Contact I3CGLOBAL for more details.
I3CGLOBAL is a dynamic and customer-centric company specializing in medical device regulatory consulting services for healthcare product manufacturers worldwide. We ensure compliance with regulations in the EU, USA, and UK. At I3CGLOBAL, we are committed to honesty, integrity, and fairness in all our dealings. This dedication has earned us the trust and respect of our customers, establishing us as a leader in the industry. Our expertise and values make us the preferred choice for regulatory consulting in the medical device sector.
