The Medical Device Regulation (MDR) 2017/745 has significantly enhanced requirements for post-market surveillance (PMS) to ensure the continuous safety and performance of medical devices in the European Union. Manufacturers must establish a robust post-market process to comply with these regulations, maintain market access, and improve patient outcomes. The post-market surveillance system shall be suited to …
The European Union’s Medical Device Regulation (MDR) 2017/745 establishes a comprehensive framework for the clinical evaluation of medical devices, ensuring their safety and performance before market introduction. Central to this framework is the categorization of clinical investigations, each serving distinct purposes in the device development lifecycle. The primary types of clinical investigations include Exploratory, Observational, …
The European Union’s Medical Device Regulation (MDR), which came into full effect on May 26, 2021, establishes stringent requirements to ensure the safety, performance, and quality of medical devices in the EU market. Economic operators, including manufacturers, authorized representatives, importers, and distributors, play pivotal roles in ensuring compliance. This article explores the responsibilities of these …
In May 2023, the Medical Device Coordination Group (MDCG) issued MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. These significant changes are changes in design or intended purpose of medical devices. Some of these …
Stability testing is a critical process that ensures product safety, efficacy, and compliance with regulatory standards in medical devices. Under the Medical Device Regulation (MDR), stability testing takes on heightened importance due to its focus on patient safety and rigorous requirements. This article explores into stability testing, its significance, key components, and best practices for …
Transport testing, as part of the EU 2017/745 Medical Device Regulation (MDR), is crucial to ensure that medical devices maintain their safety, integrity, and functionality during transportation. Medical devices, which can vary from complex diagnostic devices to small surgical equipment, are often exposed to various stresses during shipping and handling. Therefore, it is essential to …
In recent years, the intersection of technology and healthcare has given rise to a transformative phenomenon – Software as a Medical Device (SaMD). SaMD refers to software intended to be used for medical purposes, without being part of a hardware medical device. This innovative approach to healthcare has reshaped the landscape of medical devices, offering …
In the ever-evolving field of medical device regulation, the Medical Device Regulation (MDR) has introduced significant changes to enhance transparency, safety, and traceability. One crucial aspect of MDR compliance is Trend Reporting, a mechanism designed to identify and address emerging issues related to medical devices. This article delves into the intricacies of MDR Trend Reporting, …
Manufacturers must determine the appropriate sterilization method to use for their medical device. There are two factors to determine the sterilization method. The first factor is whether the manufacturer will deliver the device as sterile, or the end user will sterilize the device. If the end user is responsible for sterilizing the device, the most …
MDCG 2020-5, issued by the European Commission (EC), is a guide that explains how to show that a medical device is equivalent to another with a CE mark. This guide is very important because proving equivalence in the EU is complex. Moreover, the EU MDR and MEDDEV 2.7/1 Rev. 4, a guide on clinical evaluation, …