进入欧洲医疗市场，不只是市场准入的问题Entering European healthcare requires more than market access.
欧盟出口准备度评估将明确您的产品可能如何分级、欧盟AI法案与 MDR 或 IVDR 如何相互作用，以及在投入大量资源之前应优先处理哪些治理、证据与部署缺口。
The EU Export Readiness Assessment identifies how your product may be classified, how the EU AI Act interacts with MDR or IVDR, and which governance, evidence and deployment gaps should be addressed before significant resources are committed.
范围明确 · 周期清晰 · 路线图可执行Defined scope. Clear timeline. An actionable roadmap.
每月仅接受有限数量的制造商评估申请，以保障高级别审阅与保密性。A limited number of manufacturer assessments are accepted each month to preserve senior-level review and confidentiality.
在投入公告机构、测试与认证资源之前，先用 2–3 周明确三个核心问题：您的产品在欧盟AI法案下可能如何分级、与 MDR/IVDR 如何衔接，以及距离治理、证据与部署就绪还存在哪些差距。
评估结束时，您将获得一份面向管理层与合规团队的中英双语路线图，为后续认证、技术文档与治理实施提供决策基础。
Before committing significant resources to notified body engagement, testing and certification, establish three things: how your product may be classified under the EU AI Act, how the AI Act interacts with MDR or IVDR, and which governance, evidence and deployment gaps should be addressed.
评估内容 · What the assessment examines
- 潜在的欧盟AI法案分级Potential EU AI Act classification
- 与 MDR 或 IVDR 的衔接关系Interaction with MDR or IVDR
- 预期用途与临床证据缺口Intended-use and clinical-evidence gaps
- 人为监督与责任归属要求Human-oversight and accountability requirements
- 治理与生命周期监测准备度Governance and lifecycle-monitoring readiness
- 优先级排序的欧洲进入路线图Prioritised European-entry roadmap
您将获得 · What you receive
依据适用的欧盟AI法案分类规则，对产品的预期用途、监管角色与潜在高风险分类路径进行分析，并评估与 MDR/IVDR 的衔接。
针对适用的 AI 法案治理要求，包括风险管理、数据治理、日志记录、人类监督、准确性、稳健性与网络安全要求进行结构化差距分析。
从当前状态到市场准入与持续合规的分阶段实施路线图，包括优先事项、关键依赖关系与建议时间线。
对可能涉及的公告机构、授权代表、技术文档、测试、治理与生命周期监测工作提供预算与资源规划框架，支持管理层决策。
This service is an independent governance and deployment-readiness assessment. It is not CE certification, notified-body approval, legal advice or a guarantee of European market access.
如后续进入合规实施项目，评估工作成果将直接作为实施项目的基础，避免重复工作。
If the project proceeds to implementation, the assessment outputs will form the basis of the implementation programme, avoiding duplication of work.
申请保密评估 · Request a Confidential Assessment
请简要说明您的公司、产品与当前的欧洲市场进展。LGA 中国业务部将审阅相关信息，通常在 1 个工作日内回复。Tell us briefly about your company, product and current European-market position. The LGA China Desk will review the information and normally respond within one business day.