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[Emergo, UL] Current State of UDI in Brazil: Review of RDC 591/2021 and RDC 884/2024

The Normative Instruction to announce the ANVISA UDI database, SIUD, is expected soonBackground on RDC 591/2021The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency responsible for the supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices. Recently, ANVISA enacted RDC 591/2021, whic..

[Emergo, UL] European Packaging Waste Legislation Repeals the Directive and Applies in Mid-2026

The European legislation on packaging waste (Regulation (EU) 2025/40) was adopted late last year (December 19, 2024) and published in the Official Journal of the European Union (OJEU) in January (January 22, 2025), repealing Directive 94/62/EC. Most provisions start to apply on August 12, 2026. Directive 94/62/EC was concise. Regulation 2025/40 has 188 recitals, 71 definitions, 71 articles, and ..

The European Commission (EC) released 54 Questions & Answers on In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Performance Studies, MDCG 2025-5. This follows the analogous guidance for the Medical Devices Regulation (EU) 2017/745 MDR) clinical investigations from 2021 (MDCG 2021-6, revised 2023). This has been a long-awaited guidance document. In the interim, many competent..

If guidance on medical device software (MDSW) were a series, we just got three episodes in one week. Kicking off the triple release was MDCG 2025-4, released on June 16, which tackled the safe deployment of medical device apps on digital platforms. On June 17, a revised MDCG 2019-11 version clarified the qualification and classification of software under MDR/IVDR and introduced the interplay wi..

Introduction Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect and diagnose skin cancers (e.g. melanoma) etc. These apps are directly available on app platforms for download and u..

In our daily lives and also in the medical field, patients and healthcare professionals are increasingly using apps. On June 16, the European Commission (EC) published “MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms.” While the EC has published several pieces of guidance on MDSW already (our next update will be on the MDCG 2019-11 rev..

Scope and purpose of this document This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on:• the criteria for the qualification of software falling within the scope of the Medical Device Regulations, including Medical Device Artificial Intelligence (MDAI),• the application of the classification criteria under those regulations to MDSW and• inform..

Introduction This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR). It also contains information of relevance to manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies. Throughout this document, the te..

Introduction This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions (FAQ) document is primarily aimed at (but not limited to) medical device manufacturers, notified bodies and competent authorities. All..

Many medical device manufacturers struggle when it comes to choosing from among the wide variation of date formats used around the world. The format of dates (date/month/year, year/month/date or month date year) still poses a morass to medical device manufacturers. As a global consultancy, we understand the importance of respecting regional conventions. We also recognize different preferences. H..