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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, …
On December 16, 2025, the European Commission adopted a new proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The proposal aims to streamline the regulatory landscape for medical devices in the EU is expected to transition from a phase of implementation challenges to a more structural, streamlined, …
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 …
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 …
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 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 …
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 …
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 …
On July 12th, the EU Artificial Intelligence (AI) Act was published in the Official Journal as Regulation (EU) 2024/1689. The European Union has officially adopted Regulation (EU) 2024/1689, a comprehensive legal framework designed to regulate the development, deployment, and use of artificial intelligence (AI) systems across member states. This landmark legislation, also known as the …
On July 09 2024, Regulation (EU) No 2024/1860 has been published. This Regulation introduces the following key changes:– a gradual roll-out of Eudamed,-the obligation to inform in case of interruption or discontinuation of supply,-transitional provisions for certain in vitro diagnostic medical devices Only IVDD legacy devices may benefit from the extended transition period if: The …