How to structure Post-Market Process within the Scope of MDR
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… Read more
Clinical Investigation Under EU 2017/745/ MDR
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,… Read more
Responsibilities of Economic Operators Under the Medical Device Regulation (MDR)
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… Read more
Medical device “significant changes” under the EU MDR
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… Read more
Stability Testing
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… Read more
MDR Transport Testing
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… Read more