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, …
Usability engineering (UE)—or human factors engineering (HFE) focuses on designing a user interface (UI) that allows people to quickly understand how to interact with a Medical Device (MD) in the most efficient and error-free manner. It supports the development of safe and effective medical design, by identifying and appropriately mitigating risks associated with usability. In …
The packaging of products plays a critical role in maintaining the sterility, safety, and efficacy of medical devices throughout their lifecycle. The International Organization for Standardization (ISO) has established guidelines and standards to regulate packaging processes in the medical industry, with ISO 11607 standing out as a cornerstone for packaging validation. Here you can find …
MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the …
CE mark is required for each medical device sold in EU. Since 26th May 2021 all new devices put on the market shall comply with the applicable requirements of EU medical device regulation. Although the transitional period can be used for current MDD certificates for Class III, Class IIb and Class IIa until 2024 and …