Clinical Evaluation and Labelling: How They Are Interlinked

ShareThoughts2025-01-23T06:22:14+00:00

How Clinical Evaluation and Labelling Work Together Clinical evaluation and labelling form two integral components of the regulatory framework under the European Union Medical Device Regulation (MDR) 2017/745. Though quite distinct, these two processes are intricately related and perform complementary functions for compliance with the requirements imposed by the GSPRs contained in Annex I of the MDR. Multiple guidance documents issued by the Medical Device Coordination Group (MDCG) provide detailed insights into this interdependence: MDCG 2020–13 emphasizes the importance of taking all necessary steps to ensure that medical devices are safe, effective, and compliant with regulatory requirements. MDCG 2021–24 explains how [...]

Clinical Evaluation and Labelling: How They Are InterlinkedShareThoughts2025-01-23T06:22:14+00:00

Clinical Evaluation Process For Combination Products

ShareThoughts2025-01-24T06:07:51+00:00

Navigating Clinical Evaluation Process for Combination Products! Combination products are a niche class of medical devices whereby two or more regulated constituents, such as drugs and devices are combined to achieve a specific therapeutic purpose. These products necessarily require careful consideration of pharmaceutical and medical device regulations that ensure compliance and demonstrate both safety, performance as well as clinical benefit. This article details the step-by-step approach and considerations that guide the Clinical Evaluation Process in the context of combination products that fall under the EU’s Medical Device Regulation 2017/745. What Are Combination Devices? Combination devices are products that either: 1. [...]

Clinical Evaluation Process For Combination ProductsShareThoughts2025-01-24T06:07:51+00:00

Successful Clinical Evaluation Report under MDR 2017/745

ShareThoughts2025-01-24T06:07:09+00:00

Key Components of a Successful Clinical Evaluation Report under MDR 2017/745 A Clinical Evaluation Report (CER) becomes an essential document in terms of safety and performance of the device to prove that a device is safe and performs as intended. These are the key components of a successful CER within the framework of MDR 2017/745. Scope and Objectives The first and foremost stage in the preparation of the Clinical evaluation report includes and emphasizes the clear definition of its respective scope and objectives. Aspects of this include defining the description of the device, of its intended purpose. This must include risk classification [...]

Successful Clinical Evaluation Report under MDR 2017/745ShareThoughts2025-01-24T06:07:09+00:00

Clinical Evaluation Of Reusable, Measuring and Sterile Class I Medical Devices

ShareThoughts2025-01-11T10:43:17+00:00

Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials. Class I medical devices can be active, such as examination lamps. However, the MDCG 2021–24 Guidance on the classification of medical devices specifies three subclasses of Class I devices based on device-specific features, that do require assessment by a Notified Body. Class I medical devices are subdivided: Class Ir (Reusable Surgical Instruments): are instruments designed for multiple use after proper cleaning and sterilization [...]

Clinical Evaluation Of Reusable, Measuring and Sterile Class I Medical DevicesShareThoughts2025-01-11T10:43:17+00:00

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