Knowledge & Resources

Introduction Manufacturers of active medical devices requiring batteries might face challenges during design and development. This might be because they have not been aware of regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC. This article is about specific topics which needs to be taken […]

In her previous article, Lisa Kamber described how small companies in the MedTech environment particularly struggle with regulatory and other typical hurdles before they can even bring their innovative products to market. For small MedTech companies aiming to navigate the complex regulatory landscape in Europe, the following recommendations can be valuable: Understand regulatory pathways early

In recent years, various data protection regulations and laws have been published globally, many mirroring aspects of the European GDPR. A key principle in these regulations is the transparency of data processing. This principle mandates that data controllers provide individuals with insights into the reasons, methods, entities, and processes involved in data processing, allowing them

Small MedTech companies in Europe face a multifaceted array of challenges, including navigating complex regulatory landscapes, securing funding, protecting intellectual property, and managing manufacturing processes. These companies also need to stay updated with rapid technological advancements, ensure compliance with regulations, and achieve clinical adoption and market access amidst stiff competition. These obstacles highlight the intricate

In the previous article about ISO 13131, our Data Privacy expert Roland Schnitter explored the structure and content of this standard. He also examined how ISO 13131 interfaces with quality management system standards like ISO 13485 and ISO 27001 and discussed the potential for effort reduction through the elimination of redundancies. So, how does ISO

ISO standard 13131 provides a framework for managing telehealth services as part of the medical device environment. It combines the baselines of standards for risk management and medical devices with regulatory requirements derived from the AI (Artificial Intelligence) Act, Data Act and GDPR. Laws / regulations / guidelines: ISO 13131:2021 ISO 13485:2016 ISO 14971:2019 ISO

It is born – EU Parliament has approved the AI Act The EU is now equipped with a brand-new regulation for the use of AI. Here are the top 3 insights: The EU has adopted a new regulation for the use of AI, intended to protect the fundamental rights of human beings and promote innovation

With effect of January 2024, Swissmedic has started with a reorganisation in order to distinct more clear intern responsibilities regarding market surveillance and medical devices. The new department Medical Device Surveillance is responsible for safety of clinical trials, materiovigilance and market monitoring of medical devices. See more infos on Swissmedic website.

The Benefits of Integrating an Information Security Management System to Medical Device Manufacturers   Medical device manufacturers face unique challenges when it comes to ensuring the security and privacy of sensitive information such as clinical data or intellectual property of design development. With the increasing prevalence of cyber threats and the need to comply with

Understanding EUDAMED – A Key Resource for Medical Device Registration in the EU In the vast landscape of medical devices, one may wonder how regulators manage the enormous amount of information related to manufacturers, product details, safety reports, and clinical trials. The answer, for those operating in the European Union (EU), is a robust, secure