Over the past years, the US FDA has announced a number of initiatives, including Ethylene Oxide (EO) Innovation Challenges and Master File Pilot programs, to advance innovation and streamline the regulatory pre-market approval process. On 8 January 2024, the US FDA announced the re-issue of the guidance titled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”, superseding its 2016 version. In this blog, we will explore what are the significant changes in the guidance; what prompted these changes; and what are the impl ..read more

Instances of misuse of the test for sterility are often encountered. The most common examples being the testing of expired medical devices to prove that the sterile shelf-life has been delivered; or the testing of products marked as sterile where there is some suspicion about a deficiency in the sterilisation process, or the packaging integrity, to determine whether the products can be used or not. Not only is this testing inappropriate for either of these purposes but it will also almost certainly lead to incorrect and misleading conclusions, perhaps even risking the very safety that such tes ..read more

After years of speculation by the medical device community, on 2 February 2024, the US Food and Drug Administration (FDA) published its final rule amending the current good manufacturing practice (CGMP) requirement of the Quality System Regulation (QSR) to incorporate by reference, and thereby align more closely with, the international consensus standard ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. The new regulation is called the Quality Management System Regulation (QMSR) Final Rule and is the latest significant regulatory change affecting ..read more

The medical device industry is immersed in innovation, consistently pushing the boundaries of what is possible in healthcare. Amidst these advancements, two essential concepts have emerged that are seen as both enablers and inhibitors to innovation: Sustainability and the circular economy. While often used interchangeably, they represent distinct approaches to addressing environmental, economic, and global supply chain challenges. In this blog, we will explore the key differences between sustainability and the circular economy in the medical device industry ..read more

The regulation of medical devices and in vitro diagnostic (IVDs) medical devices in Northern Ireland is governed by the Windsor Framework. This means that the EU Medical Device Regulation ((MDR)(EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 have applied in Northern Ireland in line with the respective dates of application across the EU. The Medicines and Healthcare Products Regulatory Authority (MHRA) is the de facto Competent Authority for Northern Ireland and has specific requirements for registration, vigilance reporting etc ..read more

It has been more than 6 years now that ISO 9001 has been using the High-Level Structure (HLS) as outlined in the ISO/IEC Directive, Part 1. There have not been any significant problems created by the divergence of the two standards. In this update we will discuss the current activities by both Technical Committees and other activities by the ISO organization and others that could be of significance. While there are still many people that focus on the differences, it is clear that the standards continue to be used alongside each other without significant issues as there remains no direct confli ..read more

It has been more than 6 years now that ISO 9001 has been using the High-Level Structure (HLS) as outlined in the ISO/IEC Directive, Part 1. There have not been any significant problems created by the divergence of the two standards. In this update we will discuss the current activities by both Technical Committees and other activities by the ISO organization and others that could be of significance. While there are still many people that focus on the differences, it is clear that the standards continue to be used alongside each other without significant issues as there remains no direct confli ..read more

IEC 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment. These standards are issued by the International Electrotechnical Commission (IEC), a global organization that develops and publishes international standards for electrical, electronic, and related technologies and has been adopted by CENELEC without technical modification for use in Europe where it is designated EN 60601 ..read more

EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance. The specific requirements vary depending on the part and edition of the standard. Below you can find an overview of the general categories of requirements covered by EN 60601 ..read more

Several schemes operate for EN 60601 to facilitate compliance, certification, and market access for medical electrical equipment. Below we provide an overview of a few key ones ..read more