Medical devices are classified into four classes depending on their characteristics and safety profile (e.g. invasiveness , dependence on a source of energy, duration of contact with the body):
- class I, less critical, includes most of non-invasive medical devices which are not dependent on a source of energy, such as patches or glasses, and contains also two other sub-classes:
- class Im (medical devices having a measuring function, such as thermometers);
- class Is (sterile medical devices);
- class IIa, medium-risk, includes medical devices which could be invasive and dependent on a source of energy but do not interact dangerously with the body, such as contact lenses or tracheal tubes;
- class IIb, medium/high-risk, includes medical devices that interact dangerously with the body, such as ureteral stents or blood bags;
- class III, high-risk, includes most of implantable medical devices or medical devices interacting with the functions of vital organs or containing drugs or animal derivatives, such as coronary stents, joint implants, prosthetic heart valves or breast implants.
Medical devices can be marketed in Europe after obtaining the CE certification, which guarantees that they are compliant with the essential requirements established by the European legislation. CE certification is issued by an accredited Notified Body, with the only exception of class I medical devices (non-sterile and without measuring function) that can be certified directly by the Manufacturer in view of their low risk.
In Italy, the Manufacturer (or its authorized representative in Europe) must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The same requirement applies also to medical device kits, that must be registered into the same database by the Assembler. The data entry can be delegated to a third party.
Many pieces of information should be entered into the database, including name and code of the medical device, its classification (class, GMDN code, etc.), name of the Manufacturer or its authorized representative, a brief description of the medical device together with its intended use, a list of the materials contained in the medical device that comes into direct contact with the patient, sterilization data, information about re-use, scientific bibliography and other information. The CE certification must also be uploaded into the database, together with a safety data sheet and the whole packaging (box, labels and instructions for use, if present). All the information included on the packaging (box, labels and instruction for use, if any) should be in Italian. Multilanguage packaging is also acceptable if it includes the Italian language.
The registration of the medical devices in the sub-database Repertorio, in order to allow the healthcare professionals of the National Healthcare System to access all the information on the medical device entered into the database, is also advisable in the case of participations to public tenders.