西班牙醫療器械及體外診斷產品國家登記冊 – AEMPS概述

需要。含軟體或AI模組的醫療器械在登錄與審查時應提供軟體架構說明、版本管理與變更記錄、軟體驗證/確認報告、風險管理檔（依ISO 14971）、以及臨床性能或驗證數據摘要。針對AI，建議提供訓練/驗證資料說明、性能指標、偏差與監測策略，以協助監管評估。

通常所稱客製化（custom-made）設備是為單一病患依處方或醫師要求製作、非批量生產之器材。登錄與證明文件建議包含：病患處方或醫師訂製紀錄、設計與尺寸參數、材料明細、製程簡述、追溯編號及製造商之符合性聲明或技術檔案摘要。若不確定是否屬於客製化，請向主管機關或專業顧問確認。

If you will place dental implants on the Spanish market the responsible person (manufacturer or EU authorised representative) should ensure registration in the national product register where applicable. Typical registration items include device identification (model/catalogue number and UDI if available), intended purpose, classification, CE / conformity assessment references, manufacturer and authorised-representative contact details, labelling and instructions in Spanish, and a declaration of conformity or technical file reference. If the device is legacy during the MDR transition, check transitional provisions and update the record whenever the conformity route or intended use changes.

按西班牙实务，向国家登记提交的公共信息与面向使用者的标签/说明书应有西班牙语版本；技术支持文件（如检测方法、验证报告）可以以英文或原文随附以便审评，但正式发给用户的说明需西班牙语。建议同时附上英文技术文件与西班牙语翻译，减少审查往返。

嚴重不良事件需依主管機關規定立即通報。雖然具體時間視事件類別不同，但常見作法是於發現或得知後的短期內提交初步通報（例如72小時或7天），並在隨後提供完整調查報告與根本原因分析。請參照官方通報指南並保留通報與調查紀錄以便追溯。

Typical RPS fields include device identification (model, catalogue number), device classification, intended purpose, UDI (if available), manufacturer and authorised representative contact details, place of manufacture, labelling/language confirmation, and references to conformity assessment or the technical file. Be ready to supply clinical/technical summaries and a declaration of conformity when requested by the authority.

Registration is normally the responsibility of the manufacturer or their authorised representative established in the EU. A distributor typically cannot take over the authorised-representative role for registration duties. For non-EU manufacturers, appointing an EU authorised representative is the standard approach to enable proper registration and regulatory communication with the competent authority.

Minor changes to intended purpose or labelling generally require updating the existing national register entry rather than a full new registration. However, if the change affects classification, conformity assessment route, or introduces new clinical risks, a reassessment and possibly a new submission may be necessary. Best practice: update the register promptly, keep records explaining the change, and consult the competent authority if the impact on conformity is unclear.