Post Market Surveillance and Post Market Clinical Follow Up Plan

A roadmap for Post market surveillance and Post market clinical follow-up plan updates In the medical device industry maintaining high standards of product safety, efficiency and compliance is not only a legal obligation but a commitment to patient safety and innovation. European Union Medical Device Regulation (EU MDR 2017/745) and ISO13485 emphasizes the importance of post-market surveillance (PMS), Post-market clinical follow-up (PMCF) and corrective and preventive action (CAPA) in ensuring safety and effectiveness of the device once they are marketed. CAPA is a cornerstone in achieving this goal by addressing identified issues and mitigating potential risks. When integrated into PMS and PMCF systems, CAPA [...]

Post Market Surveillance and Post Market Clinical Follow Up PlanShareThoughts2025-01-23T06:25:50+00:00

Clinical Evaluation and Labelling: How They Are Interlinked

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

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

Demonstrating Equivalence Aspects

Understanding The Technical, Biological, And Clinical Aspects Of Demonstrating Equivalence The MDR (Annex XIV, Part A) emphasizes the importance of considering technical, biological, and clinical characteristics when demonstrating equivalence to other devices. The demonstration of equivalence must adhere to the requirements outlined in Part A, section 3 of Annex XIV of EU-MDR. Annex XIV part A requires that the manufacturer should demonstrate that there are no clinically significant differences in safety or clinical performance with regard to technical, biological and clinical characteristics. MEDDEV 2.7/1 Rev. 4 is a guidance document that provides guidance on clinical evaluation in the European Union. However, because [...]

Demonstrating Equivalence AspectsShareThoughts2025-01-24T06:07:33+00:00

Successful Clinical Evaluation Report under MDR 2017/745

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 & Sterile Class I Medical Devices

Clinical Evaluation of Reusable, Measuring & Sterile Class I Medical Devices 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 [...]

Clinical Evaluation of Reusable, Measuring & Sterile Class I Medical DevicesShareThoughts2025-03-31T04:37:27+00:00

Components of a PMCF Plan

Key Components of a PMCF Plan According to the European Union Medical Devices Regulation (EU) 2017/745, every manufacturer of medical devices must carry out periodic post-market clinical follow-up (PMCF) evaluations and collect and submit well-structured post-market surveillance reports regularly. It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According to the MDR Annex XIV Part B, PMCF should run continuously throughout the entire lifetime of a device. A PMCF Plan is required by the European Union Medical Device Regulation (MDR 2017/745) for Class IIa, IIb, [...]

Components of a PMCF PlanShareThoughts2025-01-07T10:36:01+00:00

ISO 13485 Certification in Saudi Arabia

ISO 13485 Certification in Saudi Arabia At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that get engaged in designing, developing, manufacturing, installing, and even supplying medical instruments. Hence the need to ascertain the quality and safety of health care devices in the modern international market. As for those companies that would look to wander [...]

ISO 13485 Certification in Saudi ArabiaShareThoughts2024-12-22T08:02:55+00:00

Update Clinical Evaluation Report

Update Your Clinical Evaluation Report Clinical evaluation report is essential because it assures that, during the entire time a medical device is on the market, assessments of its performance and safety are supported by enough clinical data. For first-time CE-marking, a clinical evaluation report is required, and it needs to be actively updated. For the duration of the device's life cycle, the clinical evaluation and its documentation should be updated with clinical data from the post-market surveillance system (PMS) and post-market clinical follow-up (PMCF). The frequency of updates is determined by your device's risk categorization and the PMS's output. Why [...]

Update Clinical Evaluation ReportShareThoughts2024-12-22T07:59:44+00:00

Medical Devices Sterilization

Medical Devices Sterilization Medical Devices Sterilization is a process that effectively destroys all microorganisms from the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. Sterility is a state of being free from viable organisms. Most surgical and medical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. [...]

Medical Devices SterilizationShareThoughts2024-12-22T07:59:50+00:00

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