What is meant by a Medical Device and what must it comply with? It is necessary to put in place a set of procedures that comply with the essential requirements set out by Legislative Decree No. 46/97 of 24 February 1997, which incorporated Directive 93/42/CEE.
The medical devices are divided into four classes (Class I, IIa, IIb and III) depending on their intended use, according to the classification rules set out by Annex IX of Legislative Decree No. 46/97.
MD are grouped depending on their complexity and potential risk for the patient. The classification is carried out in consideration of the invasiveness of the device, its reliance on an energy source (active device) and the length of time it is in contact with the body. Class I devices present minor risks in terms of safety, Class III devices present greater risks.
Regulations
Certification
Essential Requirements - Annex I
The devices must be designed and manufactured in such a way that their use, according to the conditions and intended purposes, does not compromise the clinical state or safety of patients or third-party users.
In the design and construction phase, the manufacturer must:
– Remove or reduce risks by incorporating safety;
– Take appropriate protection measures for unavoidable risks;
– Inform users of the risks, that do or do not result from faults in the protection measures taken;
– Equip the device with information about the manufacturer and information necessary for safe and reliable use;
– Ensure that nameplate data complies.
Other Requirements
Must Electro-Medical Devices meet any other requirements?
The most important procedure to put in place, and that a manufacturer must respect, is removing or reducing risks by incorporating safety. The most significant risk in active devices is electrical, therefore electrical risk in the medical devices must be considered.
To remove or reduce electrical risk, the MD must comply with specific electrical safety standards.
Also important for safety is the integration of collateral standards, including, for example, IEC 60101-1-11 (electro-medical systems for domestic use) standards.
Our communicators comply with IEC 60601-1-2 standards with 62-5 third edition classification.
Manufacturer’s Considerations
The final safety procedure is registering with the Italian Ministry of Health’s directory of medical aids.
Unfortunately, it should be noted that in Italy, many of the Class I MDs in particular that are registered in the directory do not in fact comply with the essential procedures set out by Directive 93/42/CEE transposed by Legislative Decree No. 46/97 of 24 February 1997.
This is likely due to the insufficient knowledge of standards, and to the simple registration process.