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On July 10, the General-Purpose AI Code of Practice (“the Code”) was published by the EU Commission. We previously examined the foundational requirements of transparency and copyright, which apply to all GPAI models. This regulatory update focuses on the additional safeguards that apply to GPAI models with systemic risks. The requirements also apply when these models are integrated or form part ..

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..

Implementing decision - EU - 2025/1324 - EN - EUR-Lex Implementing decision - EU - 2025/1324 - EN - EUR-LexCOMMISSION IMPLEMENTING DECISION (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of meur-lex.europa.eu

BackgroundThe introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (‘the MDR’) aims to ensure an adequate level of identification and traceability of medical devices. Basic UDI-DIs, UDI-DIs and UDI-PIs shall be assigned (in compliance with the rules of the designated issuing entities) by manufacturers to all device..

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..