The Regulation EU 2017/745 on Medical Devices introduced important changes concerning aesthetic or another non-medical purpose products but which are similar to medical devices in terms of functioning and risks.
- These products shall be covered by the Regulation
- Specifications regarding the application of risk management and clinical evaluation regarding safety will be adopted for groups of above mentioned non-medical purpose products.
- Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.
According to European Commission – Fact Sheet dated 5 April 2017, an example of involved product relates to equipment for liposuction. By extension, it is reasonable to consider that other devices, such as aesthetic laser equipment, products for disinfection or sterilization, aesthetic electrostimulators, etc. might be covered by the Regulation.
MediCon Ingegneria has the knowledge and the resources to develop and produce Medical Devices in accordance to the New Regulations. Contact us for further information !