CE Marking of Medical Devices

Different Medical devices, such as scanners, pumps and many others, must be certified in obedience to CE rules. However, it is not always comprehensible to a manufacturer whether his product is contemplated a medical device and which essentials he should consider looking on the certification, the technical documentation and the instructions for use.

The certification or medical device CE marking shows that the device observes with all European legal conditions considering safety, health, environmental and consumer shielding. Software and applications that are crucial for the working of a medical device must also be CE marked. For example, the software that is included in an MRI scanner – implanted software – must also be certified so that the scanner can be certified as well, based on Directive 93/42/EEC.

Each medical device must bear a label. Article 13.3 of Directive 93/2/EEC, Annex I dispensing an accurate list of the data that must be introduced on the label. The data differs from the manufacturer’s name and address and special storage and administering controlling up to cautions and defenses. The CE marking must also be attached to each medical device and there must be CE marking consultants to ensure the same.

The medical device CE marking, which is attached to a product or its packaging, is examined proof that a product has met the demands of the harmonized European standard, or directive; refers to Communauté Européen. Interpreted from the French, this precisely means European Community. The European Commission, which controls the program, recounts the CE Mark as a passport for goods to be sold freely within the internal European market. It is demanded by law if the product falls under one of the New Approach Directives. CE marking on a product specifies to all authorities that the product is in adherence with the crucial health and safety demands of all directives that are put on to the product.

The first step to abidance is deciding which directives apply to the product. A product may be adjusted by more than one directive. The CE mark does not reveal which directive(s) or levels apply to the product, nor will it stipulate the method of consent used to bring the product into compliance. This information is furnished by other piloting documents, such as the announcement of Conformity. The creator or the Authorized Representative attaches the CE marking to the product. It is not attached by a Notified Body.

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