医疗器械欧盟CE认证技术文件与美国FDA认证510（k）之间的差别

欧盟ce认证技术文件与美国fda认证510（k）之间的差别：

    欧盟和美国公司有义务条件有足够的技术文件证明监管机构应检查和确定安全水平，在欧盟，术语“技术文件”用于描述为i类，iia类和iib类产品编译的文件，iii类产品有一个不同的技术文件叫做：designdossier。

相当于美国的技术文件：

1.510（k）>用于与市场上已有的产品相似的产品

2.pma应用>这是iii类和高风险ii类设备所必需的。

    在技术文件中，欧盟条件以比fda条件更详细，更有条理和更具体的方式组织文件，在附件i中，mdd提出了确定zui低安全考虑因素的基本条件。这些基本条件是可能影响医疗器械安全的因素清单，例如设计，构造，包装和标签。

    对于每个适用的基本条件，技术文件还必须包括欧洲标准（en）协调标准和用于证明符合en标准的其他标准。已经制定了统一的安全标准，以提供证明符合相关指令的途径。适用于医疗器械的数百种en协调标准;其中一些适用于影响各种设备的广泛定义的因素（例如，风险评估，包装，标签和说明），而其他因素适用于更具体的领域（例如，γ或环氧乙烷灭菌）。如果没有适用的欧洲标准，可以援引其他标准，如国家标准或国际标准。

    技术文件还必须包括声称符合标准或标准中适用条款的证据-例如，风险分析结果，测试结果，安全报告，临床试验数据，与其他产品的等效性。

     好消息是，fda已经增加了所需的信息范围，包括技术和安全标准，风险分析。因此，zui近开发出全面的510（k）和pma应用的公司应满足大多数欧盟条件。然而，对于年龄较大的510（k），情况则不同，当510（k）szui初创建时，它们通常缺乏欧盟现在需要的那种技术文档。

质量 保证

    美国医疗设备制造商在无菌设备的质量体系条件方面面临更大的挑战，然后是非无菌设备，欧盟条件公司控制制造和包装环境，以实现绝育，而不会过量使用化学品。fda对灭菌采取了更为宽松的观点，允许更高水平的灭菌剂。

无菌和非无菌设备

    简单的fdai类非无菌设备应该能够满足欧盟85％的条件，欧盟和美国条件之间的差异是欧盟标签和使用的多个翻译。虽然这是一个微小的变化，但翻译可能是一个重大问题。如果公司想要在所有15个欧盟国家/地区销售设备，则可能需要使用12种语言标记翻译。

differences between eu ce certification technical documents andus fda certification 510 (k):

european and american companies are obliged to providesufficient technical documents to prove that the regulatoryauthority should check and determine the safety level. in theeuropean union, the term "technical document" is used to describethe documents compiled for class i, iia and iib products. there isa different technical document for class iii products calleddesigndossier.

technical documents e to the united states:

1.510 (k)>for products similar to those already on themarket

2. pma application>this is necessary for class iii andhigh-risk class ii e.

in technical documents, eu conditions organize documents in amore detailed, organized and specific way than fda conditions. inannex i, mdd puts forward the basic conditions for determining theminimum safety considerations. these basic conditions are a list offactors that may affect the safety of medical devices, such asdesign, construction, packaging and labeling.

for each applicable basic condition, the technical documentsmust also include european standard (en) harmonized standards andother standards used to prove compliance with en standards. uniformsafety standards have been developed to provide a means ofdemonstrating compliance with the relevant directives. hundreds ofen harmonized standards applicable to medical devices; some ofthese apply to broadly defined factors that affect variouse (e.g., risk assessment, packaging, labelling andinstructions), while others apply to more specific areas (e.g, γ orethylene oxide sterilization). if there is no applicable europeanstandard, other standards, such as national standards orinternational standards, can be cited.

the technical documents must also include evidence claimingcompliance with the standards or applicable clauses in thestandards - for example, risk analysis results, test results,safety reports, clinical trial data, and e with otherproducts.

the good news is that fda has increased the scope of informationneeded, including technical and safety standards, and riskanalysis. therefore, companies that have recently developedcomprehensive 510 (k) and pma applications should meet most euconditions. however, the situation is different for the older 510(k) s. when 510 (k) s were originally created, they usually lackedthe kind of technical documents that the eu now needs.

assurance

american medical e manufacturers face greater challengesin terms of the system conditions of sterile e,followed by non sterile e. european union condition companycontrols the manufacturing and packaging environment to achievesterilization without excessive use of chemicals. fda has taken amore relaxed view on sterilization, allowing higher levels ofsterilization agents.

sterile and non sterile e

simple fdai type non sterile e should be able to meet85% of the conditions in the eu. the difference between eu and usconditions is the multiple translations of eu labels and use.although this is a minor change, translation may be a major issue.if the company wants to sell e in all 15 eu countries, itmay need to use 12 language mark translations.