CE marking of medical devices

CetN provides manufacturer and importers with a comprehensive consulting service for all those who are required to make CE marking.

Contact us immediately if  your are a manufacturer or an importer , penalties are very severe for those who do not comply with the law.

You can call us at +386 40 269 896 or send an email to info@cetn.eu and request all the information you want.

We will give you all the necessary clarifications and we will send you a free quote for our advice.

Medical devices are NOT medicinal, although in some cases they can be ingested, are not medical health care even though they may look alike, then what are they?

(A) “medical device” means any instrument, apparatus, plant, software, substance or other product used alone or in combination, including the software intended by the manufacturer to be used specifically for diagnostic and / or therapeutic purposes and necessary for its proper functioning Of the device intended by the manufacturer to be used on human for the purposes of:

– diagnosis, prevention, control, therapy or attenuation of a disease;

– diagnosis, control, therapy, attenuation or compensation of a wound or handicap;

– study, replacement or modification of anatomy or physiological process;

– intervention on conception,

Whose principal action in or on the human body is not achieved by pharmacological or immunological means or through metabolism but whose function may be assisted by these means;

The definition is extracted from the Medical Devices Directive and we refer to it to check all subsequent points, which even better define the definitions useful for the correct understanding of the subject.

Do you need any other information or do you want a free quote?

DO NOT WAIT AND GET IN TROUBLE WITH THE LAW, CALL NOW! FIRST CONSULTANCY AND QUOTE WILL BE FREE

You can write us an email. We will respond in a very short time. The address is info@cetn.eu

The CE mark is not a joke! It is a duty and responsibility of the manufacturer / importer. It is imperative to know how to proceed with the proper procedures.

There are two ways:  You can self learn and study how to apply for it or choose to ask for help. Decide how you want to invest your time, you want to try to understand how to apply or you are willing to get the right advise and help from a trusted Company and safe time and avoid mistakes?The choose  is yours.

Our company carries out CE marking and provides advice to understand what needs to be done

We will help you overcome the difficulties of any complex subject with efficiency and professionalism.

We have worked with and for Multinationals operating in various manufacturing sectors and hundreds of Companies.

Contact us, you will always receive an immediate response from us!

 

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