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January 2025
MHRA Guidance on New Medical Devices: Post-Market Surveillance Requirements
This article explores the key updates in the MHRA’s PMS regulations, their impact on manufacturers and distributors, and the steps businesses must take to ensure compliance. Whether you are a medical device manufacturer, healthcare professional, or industry stakeholder, understanding these new requirements is essential for maintaining regulatory approval and upholding the highest safety standards.
Enhancing Accessibility in Rapid Diagnostic Tests: WHO’s New Guidance
Access to accurate and easy-to-use diagnostic tests is essential for public health, but many testing tools are not designed with all users in mind. Individuals with disabilities, mobility challenges, or low health literacy often struggle to use rapid diagnostic tests, limiting their ability to manage their health effectively. To address this critical gap, the WHO has developed new guidance aimed at improving accessibility in diagnostic testing, ensuring that no one is left behind in healthcare advancements.
MHRA: IMDRF’s Latest Guidance on AI and Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two significant guidance documents in 2025, aimed at improving the safety, effectiveness, and regulatory alignment of AI-driven medical devices and software as a medical device (SaMD). These documents provide a framework for ensuring best practices in AI-based medical devices and systematic risk assessment for medical software.
MFDS of South Korea and HSA of Singapore
The Ministry of Food and Drug Safety (MFDS) of Korea and the Health Sciences Authority (HSA) of Singapore have jointly released guiding principles for conducting clinical trials for machine learning-enabled medical devices (MLMDs). These guidelines aim to address the unique challenges posed by MLMDs in clinical research, ensuring they meet rigorous standards for safety, efficacy, and regulatory approval.
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Upcoming events
Medtech Summit
Budapest, 26-27 February
In 2025, one of the most important regional event for medtech researchers, startups, QA (Quality Assurance) & RA (Regulatory Affairs) professionals, manufactures and investors and will take place in a new two-day format. The event is unmissable due to its highly professional content on all segments of the medical device industry and the unique international business networking opportunities.
Attenders:
Katarzyna Weso?owska
Maciej Suwik
IX Health Challenges Congress
Warsaw, 13-14 March
The Health Challenges Congress is a space for debate on health care challenges in Poland. The Congress agenda, which consists of dozens of sessions every year, is the result of joint work of the editorial board of Rynek Zdrowia, the Programme Council and our partners.
Attenders:
Adam Sobantka
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