无菌医疗器械如何申请CE标志 目前我国众多医疗器械厂出口到欧盟的主要是一些一次性的无菌医疗器械，如医用纱布、针灸针、注射器、手术手套等，根据医疗器械的分类规则，主要属于Ⅰ或Ⅱa产品。如果这些产品的制造商申请CE，公告机构必须对灭菌过程进行审核。这里制造商特别要注意的是在选择符合性评价程序时，不能选择附录Ⅳ和附录Ⅵ的途径，来获得CE标志。因为该两种途径与最终检验（＆127；附录Ⅳ由公告机构进行，而附录Ⅵ由制造商自己进行）有关，而根据欧洲协调标准EN556的定义，无菌医疗器械是指在一百万件产品中是最多只能有一件带有存活的微生物污染（即每件产品上存在存活的微生物污染的机率必须等于或小于1×10-6）。为了通过最终检验的方法测试无菌，制造商得测试一百万件产品，这显然是不可能的。欧盟制定一系列相应的协调标准，对无菌医疗器械的生产环境控制、初始微生物污染控制、用于无菌产品的包装材料，灭菌过程控制等都有严格的规定，国内的无菌医疗器械制造商要获得CE标者，必须满足这些要求。
不打自己商标的医疗器械厂商是否需要申请CE标志
对于国内的众多的医疗器械出口厂家来说，必须了解MDD中关干制造商的定义，这和传统意义上的制造商概念有较大的不同。在MDD中是这样定义的：制造商是指以其自己的名义将某种医疗器械投放市场之前，对它进行设计、生产、包装和标签的负责人，而不管这些工人是否由他自己或第三方以他的名义进行的。本指令中，制造商需满足的责任也适用于那些对一种或多种现成产品进行组装、包装、加工、翻新和／或加贴标签和／或确定其预期用途，并以其自己的名义投放市场的人。
在MDD中规定制造商对CE标志负责并应担任指令中所规定的一切责任。所以，如果目前国内厂家出口的产品是以国外进口商的名义出口的，那么原则上并不需要申请CE标志。但对于Ⅱa类（包括I*）以上的医疗器械，如果欧洲的公司从中国进口并打上自己的商标，一般这些欧洲公司的公告机构会需要这些中国的实际制造商的证明。如果这些中国企业具有ISO 9000和EN 46000证书那就满足了作为分承包的要求，但如果这些国内的厂商打算今后以自己的名义在欧洲销售医疗器械，则他们也必须获得CE证书。
The Structure of the Medical Device Directive 93/42/EEC
The MDD is one of the most complex of the EU’s “new approach” directives.
It has 23 Articles and 12 Annexes. The Articles cover general items such as scope and definitions, placing products on the market and putting them into service, free movement of CE marked goods in EU, reference to harmonized standards, vigilance and incident reporting, Conformity Assessment Procedures, systems and procedure packs, Authorized Representative, consequences of wrongly affixed
CE Marking, confidentiality, etc…
Annex I
lists the so-called Essential Requirements. All medical devices must comply with these requirements （where applicable）。 Manufacturers are required to check each product type or model against each requirement, determine whether the requirement is applicable, acquire documented evidence of compliance and keep this evidence available in the technical file of the product. There are good reasons to say that Annex I is the real core of the whole Medical Device Directive.
Annex II
describes the conformity assessment route known as the “full quality assurance system” option.
Annex III
describes the conformity assessment module called EC Type examination （type test）。 Please note that type-examination alone is not sufficient for the CE-certification. In addition, Annex IV, V or VI is needed.
Annex IV
deals with the module called EC Verification （inspection and approval of product batches）。
Annex V
describes the module called Production Quality Assurance.
Annex VI
describes the module called Product Quality Assurance.
Annex VII
deals with instructions for self-certification of class I devices. Please note that this Annex also lists minimum requirements for the technical file.
Annex VIII
deals with devices for special purposes （such as custom-made products for individual patients）。
Annex IX
gives the classification rules of medical devices. A very important Annex!
Annex X
gives general provisions for clinical evaluation of devices.
Annex XI
describes general criteria for Notified Bodies.
Annex XII
gives form and size requirements for the CE-mark.
