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英国 UKCA 路径的检测要求与欧盟差异

英国 UKCA 路径的检测要求与欧盟差异

结论:技术要求高度相近,差异在程序和机构

英国脱欧之后形成了自己的符合性评估体系。对企业而言最关心的是:已经为欧盟做的检测,能不能用于英国?

总体判断是:技术层面的要求高度相近,检测数据多数可以复用;差异主要出现在程序层面——由哪类机构评估、证书由谁签发、注册和代表的要求等。

所以检测规划上,通常不需要为两个市场分别做两套试验,但程序上要分别走。

检测层面能复用什么

项目类别 复用可能性 说明
电气安全 高 技术要求基本一致
电磁兼容 高 同上
生物相容性 高 依据同一套国际标准
力学性能 高 产品标准多数相同
灭菌与包装 高 方法标准一致
软件验证 高 依据相同

复用的前提是方法标准本身在两边都被认可。 多数产品标准源自国际标准,两边都采纳,所以复用没有障碍。

需要留意的是标准的采纳状态可能存在时间差:某个新版标准在一边已经被列为可用依据,在另一边还没有。这种情况下,按较早被采纳的版本做,或者同时满足两版的要求,通常更稳妥。

哪些需要单独处理

符合性评估的执行机构。 需要由认可的机构完成评估,两边的机构清单是分开的。

证书与标志。 分别签发,不能互认。

注册与代表。 各自有要求,需要分别办理。

部分文件的形式。 声明文件的格式与内容要求可能不同。

这些都不涉及重新检测,但涉及额外的程序工作和时间。

报告的适用性

一份检测报告能否同时用于两边,取决于:

方法标准在两边都被接受;报告内容完整(方法、条件、数据、判定);实验室的能力证明被认可;报告语言符合要求。

前两条是技术性的,多数报告能满足;后两条是形式性的,需要提前确认。

实践中比较稳妥的做法是:委托时就说明报告将用于多个市场,请实验室在报告形式上采用通用写法,避免只适合某一市场的表述。

并行准备的做法

如果产品同时面向两个市场,建议这样安排:

技术文档做一套。 两边的技术文档要求高度相近,做一套主文档,针对各自的程序要求做少量补充。

检测做一次。 按两边要求的并集设计项目清单,一次完成。

程序分别走。 评估、证书、注册各自办理。

时间上错开。 如果资源有限,可以先完成一边再做另一边,利用已有的文档基础。

并行的主要收益在检测和文档,程序部分省不了。所以规划时要把程序时间分别算进去,不要以为做完一边另一边就很快。

标准差异的排查方法

虽然总体相近,仍建议逐项排查一次。方法是:

列出计划执行的标准清单;分别查这些标准在两边的采纳状态与版本;标出存在差异的项;对差异项判断技术影响——是实质性差异还是仅编辑性差异。

编辑性差异(编号、前言、引用格式)不影响技术内容,可以忽略;实质性差异(要求值、方法步骤、适用范围)才需要处理。

这项排查工作量不大,但能避免「以为一样结果不一样」的意外。

后续维护

两边的标准和要求会各自演进,可能逐渐分化。建议建立定期核对的机制,而不是一次确认之后长期沿用。

实际操作中,可以在每次产品变更或延续时顺带核对一次,成本不高且不容易遗漏。

两边分化的可能

目前两边的技术要求高度相近,但这个状态不是永久的。各自的标准清单、指定机构、程序要求都在独立演进,长期看分化是可能的。

所以企业不应当把「两边一样」当作永久假设,而应当在每次产品变更、标准换版、或者延续时做一次核对。核对的成本很低,而假设失效的代价可能是整批产品无法销售。

资源有限时的优先级

如果资源不足以同时推进两个市场,优先级判断依据是:市场规模与销售计划;准入周期的长短;以及哪一边的要求更严(先做严的,后做松的可以复用)。

先做要求较严的那边,通常是更经济的顺序,因为反过来往往要补测。

检测报告的市场标注

有些实验室会在报告上标注适用的市场或法规。这种标注看似方便,实际可能带来限制——标注了某一市场的报告,用于另一市场时可能被质疑适用性。

更通用的做法是报告只陈述技术事实:用了什么方法、测得什么数据、依据什么判定。至于这份数据用于哪个市场,由使用方判断。这样一份报告的适用面更宽。

产品标识的差异

两边的合格标识不同,产品上的标注要相应处理。对于同时销往两地的产品,需要决定是做两种版本还是在同一产品上同时标注。

这个决定会影响生产和库存管理,也可能影响包装和说明书的设计,建议在产品定型阶段就确定,而不是等到准备出货时才发现要改。

代表与责任主体

两边都要求有境内的责任主体,但具体职责和要求不完全相同。与检测相关的一点是:责任主体可能需要能够提供技术文档,其中包括检测报告。

所以检测报告的保管和提供安排要与责任主体沟通清楚,包括在需要时多久能提供、用什么语言、是否需要认证副本。这些细节在选定责任主体时一并约定,比事后协调要省事。

我们的做法

承接面向多个市场的委托时,我们会在方案阶段确认各市场的标准要求,找出重叠和差异,按并集设计项目清单。这样出来的清单可能比单一市场多几项,但避免了后续补测。

报告形式上,我们会采用通用写法并提供英文版本,减少后续为不同市场调整的需要。这些要求建议在委托时提出,报告出具后调整格式需要走更正流程。

如果你的产品同时面向英国和欧盟,想确认检测能不能一次做完,可以把产品资料和目标市场发过来一起理清单,或者直接联系:132 4819 8029。能力范围见服务介绍,流程见检测流程,其他问题见常见问题。

English version

Conclusion. The United Kingdom operates its own conformity assessment framework following departure from the European Union. The question manufacturers care about is whether testing done for the European market can serve the British one. Broadly, the technical requirements are closely aligned and most test data can be reused; the differences sit at the procedural level, covering which bodies perform assessment, who issues certificates, and registration and representation requirements. Testing planning therefore rarely needs two separate programmes, while the procedures must be followed separately.

What can be reused. Electrical safety, electromagnetic compatibility, biocompatibility, mechanical performance, sterilisation and packaging, and software verification all carry high reuse potential, because the requirements derive from the same international standards adopted on both sides.

Reuse presupposes that the method standard is recognised in both. Most product standards originate internationally and are adopted in both, so this is rarely an obstacle. Watch for timing differences in adoption: a new edition may be listed as a usable basis on one side before the other. Working to the earlier-adopted edition, or satisfying both, is usually the safer course.

What must be handled separately. The body performing conformity assessment, since the lists of recognised bodies are separate. Certificates and marks, which are issued separately and are not mutually recognised. Registration and representation, each with its own requirements. And the form of certain documents, where declaration formats and content may differ. None of these involves retesting, but all involve additional procedural work and time.

Whether a report serves both. It depends on the method standard being accepted in both, the report being complete with method, conditions, data and acceptance basis, the laboratory's capability evidence being recognised, and the report language meeting requirements. The first two are technical and most reports satisfy them; the second two are formal and warrant confirming in advance. In practice the safer course is to state when commissioning that the report will serve several markets and ask the laboratory to use generally applicable wording rather than expressions suited only to one.

Running preparations in parallel. Maintain one technical file, since requirements are closely aligned, with modest supplements for each procedure. Test once, designing the item list to the union of both sets of requirements. Follow the procedures separately for assessment, certification and registration. And stagger the timing where resources are limited, completing one and then using the established documentation for the other. The savings come from testing and documentation; the procedural work cannot be avoided, so allow for it separately rather than assuming the second market follows quickly.

Checking for standard differences. Although broadly aligned, a clause-level check is worthwhile. List the standards you intend to apply; check the adoption status and version of each on both sides; mark the differences; and judge whether each is substantive or merely editorial. Editorial differences in numbering, forewords and citation format do not affect technical content and can be ignored. Substantive differences in requirement values, procedural steps or scope need attention. The exercise is small and prevents the unwelcome surprise of assuming equivalence and finding otherwise.

Maintaining over time. Requirements on both sides evolve independently and may gradually diverge, so establish a periodic check rather than relying indefinitely on a single confirmation. In practice this can be attached to each product change or renewal, which costs little and is unlikely to be forgotten.

How we handle it. For multi-market work we confirm the requirements of each market at the planning stage, identify overlap and difference, and design the item list to the union. The resulting list may carry a few more items than a single market would need, and it avoids later supplementary testing. We use generally applicable wording in reports and provide English versions, reducing the need for later adjustment. These requirements are best raised when commissioning, since format changes after issue require a correction procedure.

Send us the product information and target markets and we will work out the item list. Phone or WeChat: +86 132 4819 8029.