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State of the Art in Clinical Evaluation: A Strategic Approach to MDR Compliance Introduction The term “State of the Art,” often abbreviated as SOTA or SoA, has gained significant traction in the realm of clinical evaluation, especially with the updates in the EU Medical Device Regulation 2017/745 (MDR) and MEDDEV guidelines. This article aims to […]

Decoding “State-of-the-Art” in EU’s Medical Device Regulation: A Comprehensive Guide Introduction The term “state-of-the-art” is a recurring theme in the European Union’s Medical Device Regulation (MDR), which became effective in May 2022. While the term is frequently mentioned, its precise definition within the MDR remains elusive. This comprehensive guide aims to dissect the term “state-of-the-art”

Exploring the Ambiguities of MDR: Understanding “State-of-the-Art” in Medical Device Regulation Introduction The term “state-of-the-art” is frequently used in the context of the European Union’s Medical Device Regulation (MDR), which came into effect in May 2022. Despite its frequent appearance, the term remains undefined in the MDR, leaving medical device manufacturers and notified bodies in

State of the Art in MDR: Exploring the Evolving Terrain of Medical Device Requirements Introduction: The Medical Device Regulation (MDR) is a dynamic framework, continuously adapting to the rapidly evolving landscape of medical technology. A pivotal concept within this regulatory framework is the “State of the Art,” a term that encapsulates the current level of

Clinical Evaluation of Medical Devices: A Regulatory and Practical Paradigm Introduction: In the meticulous pathway of medical device development, Clinical Evaluation emerges as a pivotal phase. It is a stringent requirement dictated by the Medical Device Regulation (MDR) aimed at ensuring the safety and performance of medical devices. This blog post endeavors to unravel the

Delving Into the Clinical Evaluation Report: A Pivotal Step in Medical Device Validation Introduction: The journey of medical device development is laden with regulatory hurdles, aimed at ensuring the highest standards of safety and efficacy. Central to this regulatory framework is the Clinical Evaluation Report (CER), a critical document that encapsulates the clinical evidence supporting

Unveiling the Clinical Evaluation Process in Medical Device Development: A Regulatory Imperative Introduction: In the stringent domain of medical device development, the Clinical Evaluation process emerges as a pivotal step mandated by the Medical Device Regulation (MDR). This process is indispensable in validating the safety and performance of medical devices, forming a crucial aspect of

Interplay of Clinical Evaluation and Clinical Investigation: A Regulatory Perspective In the domain of medical device development, adherence to the Medical Device Regulation (MDR) mandates a stringent scrutiny of the safety and performance of medical devices through two key processes: Clinical Evaluation and Clinical Investigation. These processes embody the regulatory rigor, ensuring that the medical

Bridging the Divide: Intersecting Realms of Clinical Evaluation and Clinical Investigation In the intricate realm of medical device development, understanding the nuances between Clinical Evaluation and Clinical Investigation holds the key to ensuring both the efficacy and safety of the devices in question. The landscape is further complexified by the stipulations laid down by the

Comprehensive Guide to Clinical Evaluation of Medical Devices: Interpretation and Application of EU MDR and MDCG Guidelines Introduction The objective of this blog post is to elucidate the regulatory landscape surrounding the clinical evaluation of medical devices, as governed by the European Union Medical Device Regulation (EU MDR) and the Medical Device Coordination Group (MDCG)