MDR Trend Reporting

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, …

Medical Device Sterilization Methods and Validation Process

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 Clinical Evaluation – Equivalence

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, …

EN 62366 Usability Engineering

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 Evolution and Impact of Software as a Medical Device (SaMD) in Healthcare

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 …

Packaging Validation of Medical Devices

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

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 …

EU Medical Device Regulation – How to CE Mark a Medical Device?

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 …

The Number of Medical Device Notified Bodies is increasing

EU Commission has announced EU MDR 2017/745 designation of 42th notified body (NB). The number of Notified Bodies is expected to increase with the issue of the amendment for MDR extension on 20 March 2023 .With increasing number of NBs manufacturers may find more options to certify their devices. Since beginning of 2019, when the …

IVDR EU 2017/746 CE Marking

The change journey of the EU medical device directives since 2012 was completed on 5 May 2017 with the publication of EU 2017/745 and EU/2017/746 in the EU official journal. EU 2017/746, which we are accustomed to briefly refer to as IVDR, entered into force on 26 May 2022. However, due to the COVID 19 …