CE marking of medical devices
IF YOU WANT TO PLACE YOUR MEDICAL DEVICE ON THE EUROPEAN MARKET, YOU HAVE TO KNOW THAT THE CE MARKING OF MEDICAL DEVICES IS REQUIRED.
All the products used to intervene on a subject named patient to improve his health are called MEDICAL DEVICES. These devices can intervene directly or indirectly and all fall under the following laws:
- Regulation 2017/745/EU
- Regulation 2017/746/EU
- Directive 93/42/EC in force until 2020
- Directive 98/79/EC in force until 2020
Medical devices are divided into various classes of risk according to their type of use. To mark CE these products, different procedures must be followed depending on their class. After the CE marking of medical devices, registration with the Ministry of Health is always required (except in the case of a custom-made medical device). We can help you to registrate your product, feel free to ask us informations about.
IN-DEPTH
WHO HAS TO MAKE THE
CE MARKING OF MEDICAL DEVICES?
The CE marking is mandatory for those who put into free circulation within the European Community a product that falls within the definition of a medical device.
If you are the manufacturer, you need an authorised representative in Europe to make the CE marking.
THE ESSENTIAL HEALTH AND SAFETY REQUIREMENTS SHOULD BE
SATISFIED IN ORDER TO ENSURE THAT MEDICAL DEVICE IS SAFE
A MEDICAL DEVICE WITHOUT CE MARKING IS ILLEGAL IN EUROPE
ONLY A RESIDENT IN THE EUROPEAN COMMUNITY CAN CARRY OUT THE CE MARKING
LAW REQUIRES THE TECHNICAL FILE FOR MEDICAL DEVICES
How a medical device is defined?
The law gives the below definition to defines the medical device:
‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of. conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Who has to manage the technical file?
The new Regulations introduce important news on the management of the technical file.
One of these concerns the need for a professional figure, who responds to the correctness and continuous management of the technical file.
If this figure is not within the company, an external adequate professional person can be used.
CeAdvice, in addition to the adaptation of the technical file, offers the technical file management service by our engineers, who have the necessary skills and experience to perform this activity.
Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the medical device with the essential health and safety requirements.
THE CE MARK
BASE INFOS
Do you know the basic information on CE marking?
What’s the CE marking?
The CE marking is a mandatory procedure for all products covered by a Community directive, it must be carried out by the manufacturer or the authorised representative established in the European Union, which declares by means of the Declaration of Conformity (or Performance for construction products only), which the product complies with the safety and health requirements, provided for in the relevant Community directives or regulations in addition to avoid problems with the authorities and the police in case of control.
Who should make the CE marking?
The CE marking is a process that must be carried out by the product manufacturer or his authorised representative established in the European Community who, with the Declaration of Conformity, declares that the product complies with the safety and health requirements of the law. You can ask for advice on CE marking, but you can’t let others do it, unless you name a representative, that is, a legal agent. In any case, anyone who sells the product under his own name is totally responsible for it.
If you live in a non-EU country, can you mark CE your product?
No, the directives clearly clarify that ONLY a resident in the European Community can carry out this activity.
Therefore, if a non-European subject supplies a CE marked product, that mark is always illegal, even if the product complies with European laws. It is necessary to distinguish between the product, which enters the EU market, and the producer, if it is outside the EU, the law demands a substitute (importer or agent).
Beware of scams! What is the CE certificate?
The certificate or certification is NOT the CE mark, on this aspect there is a lot of confusion and many scams, for customers and for the authorities. At most, a certificate is a component of the CE mark but does not replace it. Never!
On the CE marking many have an interest in creating confusion! We help you to clarify and you can have our assistance and advice.
We're here to help you!
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