EU Publishes Regulation (EU) 2024/1860 Amid Device Supply Chain Concerns
In response to increasing concerns over supply chain stability and its impact on healthcare delivery, on June 13, 2024 the European Union published Regulation (EU) 2024/1860 of the European Parliament and of the Council which amends both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to introduce new obligations for companies facing […]
The EU AI ACT: Implications for the Medical Device Industry
The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]
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 […]
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 […]
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 […]
FDA Third Party Review Programs
In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]
The MHRA Roadmap: Navigating the UK Market
While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition: Additionally, self-declared CE-marked […]
FDA Announces the Issuance of Final Rule Amending the Quality System Regulation
Today, the resounding echo of the starting gun reverberates globally, signaling the commencement of a pivotal two-year transition period for device manufacturers and importers. This period marks the urgent need for them to adapt and enhance their quality management systems in alignment with the requirements of the Quality Management System Regulation (QMSR). The long-awaited final rule, issued by the FDA, has been a focal point of anticipation within the medical industry. The call for harmonization between ISO 13485 and the Quality System Regulations (QSRs) has persisted for decades, gaining heightened significance since its formal announcement in 2018 and the subsequent release of the proposed rule in February 2022.
EU Commission proposes another extension for IVDR transition
On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period. Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time […]
MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
