The EU IVDR Impact on Clinical Trials
The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]
ANVISA’s Recognition of Decisions by International Regulators: Facilitating Access to Medical Devices in Brazil
In the realm of healthcare, access to safe and effective medical devices is paramount to ensuring quality patient care. Brazil, as one of the largest healthcare markets in the world, has been taking significant strides to streamline its regulatory processes and facilitate the entry of medical devices that have been approved by reputable international regulatory […]
Select Updates for the Premarket Cybersecurity Guidance: What You Need to Know
FDA is proposing to selectively update the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
FDA Whitepaper: Artificial Intelligence & Medical Products – What You Need to Know
Artificial intelligence (AI) holds immense potential to revolutionize healthcare, offering advancements in medical product development, improving patient care, and augmenting the capabilities of health care practitioners. With a shared commitment toward fostering innovation and upholding quality, safety, and effectiveness, FDA plans to align their efforts to advance the responsible use of AI for medical products. […]
Guidelines Updated on Phthalates
Phthalates are a group of chemicals commonly used as plasticizers to make plastics more flexible, durable, and transparent. Recently, the EU Commission requested the first update from SCHEER since 2019, to which SCHEER has responded by providing information as to how the manufacturing community has evaluated potential alternatives to the use of phthalates and how this will impact both the design and use of their products.
Final Rule on the Use of Ethylene Oxide
The use of Ethlyene Oxide (EtO) in the sterilization of medical devices has been under debate for years, dating back to 2019 when the US Food and Drug Administration (FDA) announced its Innovation Challenges to industry. Challenge 1 was to identify safe and effective sterilization methods or technologies for medical devices that do not rely […]
IMDRF: Updates on Current Working Groups
The International Medical Device Regulators Forum (IMDRF) held its 25th annual meeting in Washington, DC on March 12, 2024. Of the topics discussed was the progress of the various working groups and the mention of new guidance documents harmonizing global marketing review requirements, which is highly sought after by industry. Working groups that were highlighted […]
MDR Compliance
Challenge: A long-standing client, a small company specializing in innovative minimally invasive endosurgical devices, needed to maintain their existing CE Mark while updating their QMS to comply with the new Medical Device Regulation (MDR). Facing limited resources to implement the new regulations and update their documentation for an MDR submission, they trusted AlvaMed’s proven track […]
Remote Regulatory Assessments: What You Need To Know
Travel restrictions, brought on during the COVID-19 pandemic, forced the US Food and Drug Administration (FDA) to adapt its mode of operations with respect to field inspections by employing a remote regulatory assessments (RRA) strategy. FDA used these RRAs to ensure continuity of inspections for compliance with applicable FDA requirements where an on-site presence was not […]
Clinical Evaluations and the EU Market
Clinical evaluation is arguably one of the most important topics in the international medical device arena and the EU is no exception. As the EU regulations continue to be rolled out, albeit with a sliding timeline, industry and notified bodies are focusing on the interpretation and implementation of clinical information as it supports the end goal […]
