The CE marking of medical devices is a mandatory procedure for all products governed by the Community Regulations " medical devices and in-vitro medical devices", must be performed by the manufacturer of a product that falls under these Regulations, who declares using the declaration of compliance that your product complies with the health and safety requirements of one of these regulations.



The new Regulations, in addition to regulating the CE marking of medical devices in a clearer way, introduce important innovations on the classification of products and the management of the technical file. Medical Device Ce Marking



An important novelty concerns the need for a professional figure who is responsible for the correctness and continuous management of the technical file.



If this figure is not present within the company, an external one with adequate professionalism can be used.



In addition to proposing the adaptation of the technical file, our company offers the possibility of obtaining the technical file management service from our engineers, who have both the qualification and the experience to be able to carry out this activity.



General information on the CE marking of Medical Devices



The medical devices are those ONLY if they are directly or indirectly on the patient, to improve the health, wellbeing prevention.



When these conditions are met, the Medical Devices fall under the Regulations 2017/745 / UE and 2017/746 / UE and in the Medical Devices Directive 93/42 / EC and 2007/47 / EC and therefore must be subjected to the CE marking process and carry the CE mark.



The medical devices are divided into various classes that are: I (first), IIa, IIB, and III, and to be able to CE marking must follow different procedures depending on their class.



At the end of the CE marking process for medical devices, registration of both the manufacturer and the medical device with the Ministry of Health is required.

The in-depth study on the CE marking of medical devices



For simpler medical devices (class I), CE marking procedures involve only the manufacturer.



For more complex devices (class IIa, IIb, and III), the intervention of a Notified Body is always necessary, in different ways depending on the complexity of the CE marking to be made.



The certificates issued by the Notified Body, even when required by the directive, DO NOT replace the CE marking of medical devices, but are an integral part of it. IVDR CE MARKING



A non-European manufacturer can NOT carry out the CE marking of medical devices, even if its products comply with the laws, if it does the marking is illegal. It can appoint its EU Representative, but in any case, the person responsible for the CE marking must be European.



Regulations and Directives



Medical devices must be CE marked, applying the procedures indicated on this site and on which our company provides assistance and advice.You can consult the regulations and directives by visit our website https://www.meddevicecorp.com/