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[Emergo, UL] FDA Releases Final Guidance on Medical Device Cybersecurity

On June 27, 2025, the U.S. Food and Drug Administration (FDA) released its final guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. This builds on the foundations set by the guidance and select updates issued in 2023 and 2024, respectively, providing both a consolidated framework for cybersecurity and clarifications that reflect th..

Well-designed instructions for use (IFU) are critical to mitigate potential risks whilst confirming that the intended users can effectively use a medical device out of the box. Usability testing remains the standard for reliably evaluating the effectiveness of an IFU. However, there are a variety of evaluation methods that may assist manufacturers in refining their product labeling and IFU. In t..

The Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation from May 20 to June 14, 2024, on their proposed amendments to the Medical Devices Regulations 2002 (MDR 2002) regarding the Common Specifications (CS) requirements for certain high-risk in vitro diagnostic (IVD) devices, including COVID-19 tests. In this blog, we discuss the outcome of the consultation and th..

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..

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 ..

We at Emergo by UL continue to monitor and share regulatory updates and news after the first quarter. We’ve divided the developments this quarter into three topics: regulatory data, quality management system (QMS) and medical device software (MDSW). If there is one theme, it is the influence of the International Medical Device Regulators Forum (IMDRF), Medical Device Single Audit Program (MDSAP)..

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..

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..

On June 17, 2025 (one day following the release of MDCG 2025-4), the EU commission published a revision to MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. While there are no substantive changes, several meaningful clarifications are worth mentioning. Refined scope to include AIThe term medical device ar..