(scope: Design, manufacturing, distribution and servicing of medical technical furnishings and accessories for hospitals and other health care facilities.)

(scope: Design, manufacturing, distribution and servicing of medical technical furnishings and accessories for hospitals and other health care facilities.) 

(for the implementation of the Environmental Management System on the site of: Viale Veneto, 2 - Frazione Villatora - 35020 Saonara (PD) Italia Via Canada, 11/4 – 35127 Padova (PD) Italia) These certifications are released by TÜV Austria.

Evaluation procedures for medical devices. 

According to the 46/97 Legislative Decree, the phases of CE branding procedure of medical devices are:

1. According to the rules contained in the IX attachment of the 46/97 Legislative Decree, classification is the first act the producer has to do to identify the class of the device and to adopt the consequent branding procedures.

2. To be CE branded, whichever medical device has to correspond to the so-called “essential requirements” exposed in the I attachment of the 46/97 Legislative Decree. We are talking about safety and efficacy requirements which have to be owned by both the devices and their productive system. Indeed, as the I attachment declaims “devices have to be planned and produced so that their utilization will not compromise patients’ clinical condition and safety, nor users or third’s safety and health, when used in the expected terms and for the expected aims, it being understood that the possible risks have to be of an acceptable level, considering the benefit produced in the patient, and compatible with an high protection level for health and safety”. This means that – to produce a medical device in compliance with the 46/97 Legislative Decree – the producer will have to prove that not only his/her product but also the productive process in all its different aspects (planning, making, checking, etc.), respect the essential requirements. The list of the essential requirements is divided into two parts: the first one dedicated to the general requirements, completely pointed towards the intrinsic safety of the devices; the second one – divided further into 7 groups – covers all the planning and executive aspects of the device. The more high is the device riskiness, the more will be the safety guarantees the producer will have to supply for the device production.

3. According to the VII attachment of the 46/97 Legislative Decree, for the I class the producer will be allowed to brand the product as CE and insert it into the market only after having drawn up a certificate of CE compliance to the essential requirements. Through this document the producer guarantees and declares that his/her products respect legislative dispositions. In any case the company has to own all the technical documents required to demonstrate the safety of the produced device. The CE compliance statement is the easier procedure of CE branding. It is a mere statement of responsibility undertaking, without the intervention of a Notified Entity. In respect of the fact that the sterilization and the size function represent processes of high relevance for the purposes of safety, for the sterilezed and/or size function endowed devices - even if of I class, the mere compliance statement will not be sufficient and the producer will have to supply guarantees regarding the reliability of the adopted proccesses. In this case, in addition to the dispositions of the VII attachment, the producer has to conform to one of the procedures provided in the IV/V/VI attachments, on his/her choice.