歐盟醫材法規監管簡化要點暨臺灣廠商市場准入機會【本期企劃】 試閱
Highlights on EU Medical Device Regulatory Simplification and Market Access Opportunities for Taiwanese Manufacturers
歐盟於2025年12月提出「簡化醫療器材及體外診斷醫療器材相關規則的法規提案」，包括醫療器材法規在流程簡化、減輕行政負擔、認證的可預測性與成本效益、專家小組的協調等面向之調整。本文從歐盟醫療器材法規調整之主要內容進行重點摘錄，並據此討論臺灣廠商前進歐盟市場的准入建議做法，包括從打破臨床資料轉化與資料治理瓶頸、提供諮詢小組預擬風險等級與監管框架、銜接全生命週期的場域驗證這三個面向提出技術面、法規面及市場面之因應建議。
The European Union put forward a legislative proposal to simplify rules concerning medical devices and in vitro diagnostic medical devices in December 2025; the proposal includes adjustments such as procedural simplifications, a reduction in administrative burdens, improved predictability and cost-effectiveness of certification, and enhanced coordination among expert panels. This article highlights the regulatory adjustments for medical devices in the European Union and discusses recommended strategies for Taiwanese manufacturers seeking to enter the European Union market. It offers response recommendations—covering technical, regulatory, and market dimensions—focused on three suggestions: overcoming bottlenecks in clinical data translation and data governance; utilizing advisory groups to determine preliminary risk classifications and regulatory frameworks; and integrating real-world validation across the product lifecycle.
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