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Shanghai Global Testing Services Co., Ltd. (GTS) is an experienced certification authority focusing on providing the third party inspection, identification, test and certification service. We offer many testing services in the fields of industrial products, consumer goods, trade security, etc., involving harmful material, safety, EMC, material analysis, textile, shoes, leather, toys, and many other testing programs.
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 Medical Devices (MDD)

Medical Devices (MDD)

Directives

As a first step, you need to verify whether your product(s) fall(s) within the definition  of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active  implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these  conditions are fulfilled, Directive 93/42/EEC applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.

 

However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or environment) can apply.

 

Directive 93/42/EEC on Medical Devices (MDD) specifies general requirements that the product has to meet in order for the manufacturer to affix the CE marking. These are the so-called Essential Requirements that are listed in Annex I to the MDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex X to Directive 93/42/EEC.

 

Check conformity

Subject to the class of the medical device, the manufacturer has different options as to how to assess the conformity of the medical device. The stringency of the conformity assessment procedures depends on the class of the medical device. For each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes, what has been verified.

 

 

Whether the involvement of a Notified Body has been necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.


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