Noticias y novedades
EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire regulatory strategy under the European Medical Device Regulation (EU) 2017/745 (MDR). Specifically, this classification dictates your compliance pathway in the European Union. Consequently, it impacts clinical data requirements and Notified [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means dealing with a barrage of redundant Quality Management System (QMS) audits. For manufacturers looking to expand globally, this replication of effort consumes valuable time, capital, and resources. The Medical Device [...]
FDA QMSR Explained: What the New Quality System Regulation Means (and How to Prepare)
The wait is over, and the transition window is officially closed. On February 2, 2026, the FDA fully enacted its new Quality Management System Regulation (QMSR). This update completely overhauls the legacy 21 CFR Part 820 (QSR), replacing old, US-centric rules with an internationally [...]
Swissmedic Announces Medical Device Registration Fees for Swissdamed
Swissmedic has published further details on the registration fees that will apply to medical devices, systems and procedure packs registered in the swissdamed database ahead of the mandatory registration requirements coming into force on 1 July 2026. According to the [...]
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise ( Cloned )
CMC Medical Devices Joins Registrar Corp: Expanding Global Regulatory Expertise [Malaga, Spain, and Hampton, VA — October 30, 2025] — CMC Medical Devices (CMC), a Spain-based global regulatory consulting firm specializing in medical devices and in vitro diagnostics (IVD), has [...]
New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078? On 17 October 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182 regarding harmonized standards applicable to surgical clothing and drapes, medical face masks, and sterilizers for medical [...]
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls under [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare delivery. Software is no longer just an accessory to medical devices, it can operate as a medical device on its own. To guarantee safety and performance, the Therapeutic Goods Administration [...]
