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As professionals in the medical device industry, it’s essential to stay up to date with the latest tools, trends, and technologies to keep our clients ahead of the curve. The latest changes we want to bring to the attention of medical device stakeholders’ are the new standards released by the U.S. Food and Drug Administration department.

Post-Market Clinical Follow-up or PMCF refers to activities that help provide data, documentation, and evidence regarding a medical device’s safety or performance. PMCF is one component of post-market surveillance (PMS) activities for medical devices. The purpose of PMCF is to confirm the clinical performance and safety of the device in real-world use and help manufacturers manage acceptable risk. PMCF and PMS data safety and performance data collected from real-world device usage are expected to feed back into a re-evaluation of Risk determination over the life cycle of the device.

The Food and Drug Administration (FDA) drug approval process is a core component of drug discovery in the United States. Whether it’s a cancer drug or other medication, medical treatments in the U.S. have to go through a specific process to make sure they’re safe and effective before being released to the public. The FDA oversees the process from start to finish and even after approval. Only after a thorough analysis by a team of CDER scientists (Center for Drug Evaluation and Research) can new medicines and treatments be approved for sale in the United States. They review each drug closely using an independent team of professionals and scientists who evaluate the safety, efficacy, and labeling of the drug product.

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. Some changes may be relatively minor, such as the change in terminology from Essential Requirements to General Safety and Performance Requirements, while others may have a significant impact on the need for clinical evidence and evaluation, leading to modifications in CER processes and collection of additional data from clinical investigations to support a product undergoing review along with an improved quality management system.

A Clinical Evaluation is used to demonstrate a medical device’s safety and performance and its overall positive benefit-to-risk ratio by analyzing clinical data. Clinical Evaluation is part of a series of guidelines dealing with questions of application of EU-Directives on Medical Devices.

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