ElendiLabs
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。
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January 8, 2026
Approximately 5 minutes
National Registers of Medical Devices and IVDs in Spain – AEMPS Overview
Purpose of National Registers
The national registers managed by AEMPS serve to:
- Ensure traceability of medical devices and IVDs throughout their lifecycle.
- Facilitate market surveillance, vigilance, and post-market activities.
- Support compliance during the transitional periods of MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
- Provide a centralized database for competent authority oversight and public transparency.
These registers complement the European EUDAMED database and apply particularly to devices not yet fully transitioned or requiring national-specific obligations. Registros nacionales de productos CCPs/RPS - AEMPS
Main Registers and Databases
- Registro de Productos Sanitarios (RPS): The core national register for medical devices and IVDs placed on the Spanish market.
- Mandatory for Class I self-certified devices, custom-made devices, systems/procedure packs, and certain legacy devices during transition.
- Includes device identification, manufacturer/responsible person details, and status updates.
- Registro de Operadores: Registry of economic operators (manufacturers, importers, distributors) involved in medical devices and IVDs.
- Registro de Instalaciones: Registry for facilities where devices are manufactured, stored, or distributed.
- EUDAMED Integration: National data feeds into the EU database; transitional national registration remains required until full EUDAMED functionality.
Registration Requirements
- Who must register: Manufacturers (or authorised representatives for non-EU entities), importers, and distributors for applicable devices.
- When: Before placing on the market or during transitional periods for legacy devices.
- Information required: UDI (where applicable), device classification, intended purpose, labelling details, responsible person, and conformity assessment details.
- Language: Information submitted in Spanish; labelling and instructions must meet national requirements.
Failure to register can lead to market restrictions, administrative sanctions, or product withdrawal.
Vigilance and Surveillance Linkage
Registered devices are monitored through the vigilance system:
- Serious incidents and field safety corrective actions reported directly to AEMPS.
- AEMPS coordinates investigations, risk assessments, and communications.
- Data from national registers support rapid identification and action on non-compliant or unsafe products.
Practical Guidance
AEMPS provides online portals for registration, detailed instructions, FAQs, and updates on transitional provisions. Manufacturers and operators should consult the registers section for current requirements, especially during the ongoing MDR/IVDR transition. The system enhances patient safety and regulatory efficiency in the Spanish market while aligning with EU harmonisation goals. Registros nacionales de productos CCPs/RPS - AEMPS
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Questions & Answers (8)
張
張敏
Guest
我們要在西班牙註冊一款客製化的矯形器材，請問「客製化」在國家登錄系統中如何定義？需要哪些文件證明是客製化產品？
ElendiLabs
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。
陈
陈晓
Guest
I manufacture dental implants outside the EU. Do I need to register each implant model in the Spanish national register before placing on the Spanish market, and which documentation is typically required?
ElendiLabs
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.
李
李伟
Guest
我们是一家中国公司，想把一个体外诊断试剂（IVD）注册到西班牙市场。请问样品检测方法和英文说明书能否一起提交，还是必须提交西班牙语说明书？
ElendiLabs
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。
張
張敏
Guest
如果產品在登錄後發生嚴重不良事件，我們需要在多長時間內向主管機關通報？
ElendiLabs
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。
C
Carlos
Guest
For a Class I self-certified device already on the EU market, what key fields should we expect to fill in the Spanish Registro de Productos Sanitarios (RPS)?
ElendiLabs
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.
M
Maria
Guest
Can a distributor register devices on behalf of a non-EU manufacturer in the Spanish national register, or must the authorised representative do it?
ElendiLabs
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.
C
Carlos
Guest
During the MDR/IVDR transition, if our legacy class I device already has a Spanish registrant entry but we updated the intended purpose slightly, do we need to submit a new registration or just update the existing record?
ElendiLabs
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.
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Important Disclaimer
王強
我们计划在西班牙进口一款包含软件的医疗器械（含AI诊断模块）。在注册时是否需要提供软件验证和风险评估文档？