# What is the CE Marking - Meddevicecorp

The Medical Device CE Marking is the process by which the manufacturer/importer informs the users and competent authorities that the marketed equipment complies with the mandatory legislation regarding essential requirements.

When a product is covered by several Directives that provide for the placement of the "CE" marking, it shall indicate that the product complies with the applicable provisions of all those Directives applicable to it.

However, in case one or more authorize the manufacturer to choose, during a transitional period, to apply them or not (in which case they must comply with the national legislation that is in force), the "CE" marking will only refer to compliance [**Regulatory Affairs Consultant**]([https:/](https://www.meddevicecorp.com/)/) with the provisions of those Directives that have been applied and should be indicated in the documents established by the CE Marking procedures only the references of such Directives.

Is the CE Marking necessary to sell a product?

If required. Utilizing the CE Marking, the manufacturer of the equipment indicates that it complies with the essential requirements set out in the Community Directive (s) that apply to it.

It will be placed by the manufacturer or its authorized representative within the EU Representative.

Exceptionally, when the Directive permits, it can be set by the person responsible for placing on the market in the EU.

You must place it at the end of the production phase, and with adequate dimensions (not less than 5 mm), and if possible, on the product or its nameplate.

It will be placed visibly, legibly and indelibly and it is not allowed to place signs that may be confused [**FDA 510k Consultants**]([https:/](https://www.meddevicecorp.com/fda-510k-submission/)/) with the CE Marking.

On the other hand, in addition to placing the CE Marking, the manufacturer must have the following documents ten years after the last equipment is sold:

Declaration of conformity
Technical File Record
Exceptionally, the DC related to In Vitro Devices only requests to have said documentation five years after the last equipment is sold.

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