1. Classification is the first action that the manufacturer has to make in order to identify the class of device, according to the rules contained in Annex IX of the D. Lgs. 46/97, and adopt procedures resulting markup.

2. Any medical device, to bear the CE marking should correspond to the so-called "essential requirements" set out in Annex I to the D. Lgs.46/97 This is relevant safety and effectiveness that both devices is the production system should have. 

According to Annex I, in fact, the devices must be designed and constructed so that their use does not compromise the clinical and patient safety, or the safety and health of users and possibly third, when used the conditions and for the intended purposes, provided that any risks must be acceptable given the benefits to the patient and are compatible with a high level of health protection and safety. This means that - to produce a medical device conforms to D. Lgs.46/97 - the manufacturer must demonstrate that not only its product but also the production process in its various aspects (design, manufacturing, controls, etc..) Meet the essential requirements.

The list of requirements is divided into two parts: the first devoted to the general, fully addressed the inherent safety of the devices, the second - further divided into 7 groups - covering all aspects of design and construction of the device. The higher the risk of the device, the greater will be the security guarantees that the manufacturer must provide for the production of the device.


3. For class I, the manufacturer can CE mark the product and place it on the market after having drafted a declaration of conformity with essential requirements, in accordance with Annex VII of D.Lgs.46/97. With this document, the manufacturer ensures and declares that its products meet the requirements of the Directive. The company must have all the technical documentation to demonstrate the safety of the product.  The declaration of conformity is the procedure easier for CE marking. This is a simple statement of ownership, without the intervention of a Notified Body.
As sterilization and the role of measurement processes are of particular relevance to safety devices for sterile and / or function of the measure, although the class I will not be sufficient alone declaration of conformity but the manufacturer must provide assurance on the reliability of the processes adopted.  In this case, the manufacturer must therefore follow, in addition to the provisions of Annex VII, also one of the procedures set out in Annexes IV or V or VI, at his discretion.

The procedures set out in Annexes IV, V and VI should be submitted to a Notified Body, which will be limited:

*  in the case of sterile products, to the aspects of manufacture that affect the achievement and maintenance of sterility;

*  in the case of devices which function to measure, to the aspects of manufacture that affect product conformity with the metrological requirements.


For Class IIa ask the manufacturer to the notified body the approval of its production facilities and / or its product.  The manufacturer can choose between two different

procedures:

* Annex II (full quality assurance) with the exception of point 4.

*  Annex VII (EC declaration of conformity) + Annex IV (EC verification) or V (production quality assurance) or VI (product quality assurance).


For class IIb, the manufacturer will require the approval the notified body of its production facilities and / or its product, but with more safeguards and checks.The

manufacturer can choose between two different procedures:

* Annex II (full quality assurance) with the exception of point 4.
* Annex III (EC) + Annex IV (EC verification) or V (production quality assurance) or VI (product quality assurance).


For Class III will ask the manufacturer to the notified body the approval of its production facilities and / or its product, but with safeguards and controls even more severe,

involving in particular the aspect of design. Il fabbricante potrà scegliere tra due diverse procedure applicabili: The manufacturer can choose between two different

procedures:

* Annex II (full quality assurance) including Section 4 (examination of product design).
*Annex III (EC) + Annex IV (EC verification) or V (production quality assurance).


All documentation must be kept at the disposal of the public health for at least five years after the date of manufacture.


The devices, for which there is no CE marking, subject to compliance with the essential requirements must be accompanied by a statement of compliance in

accordance with the procedures described in Annex VIII. The declaration of conformity must include in particular the following information:

* data that can identify the device in question;
* a statement that the device is intended to be used exclusively for a particular patient, with the name of the patient;
* the name of the physician or authorized person who has prescribed the device and, if applicable, the name of the hospital;
* the specific characteristics of the device under a prescription;
* the statement that the device meets the essential requirements set out in Annex I and, where appropriate, a statement of the essential requirements that have not

been fully met, with adequate justification.


Furthermore, a manufacturer of devices tailored "undertakes to make available to the competent national authorities the documentation allowing an understanding of the

design, manufacture and performance of the product, thus allowing the assessment of conformity with the requirements of D. Lgs.46/97. Lgs.46/97. All documentation,

including the declaration, it must be kept available for at least five years.


The systems and kits for the operating field, where there are a number of medical devices, even from different companies and different classes, assembled to one

another may be consisting of:

* All devices individually CE marked, in a non-sterile packaging. These assemblies must not be re-marked CE.  The assembler for these products must produce a

statement of which was checked for mutual compatibility of the devices making up the kit as instructed by the manufacturers, who packed the kit and has provided

relevant information to users with the instructions of the manufacturers and the whole activity is subjected to appropriate methods of verification and internal control.This

statement shall be forwarded to the Ministry of Health;
* all devices individually CE marked, in a sterilized dall'assemblatore. In this case, the assembler, in addition to the requirements provided in the preceding paragraph

shall follow the procedures described in Annex IV or V or VI.The application of this procedure and the intervention of the notified body are limited to the sterilization

procedure;
* devices not CE marked or not all individually marked CE. In this case all devices assembled it becomes a stand-alone device and as such is subject to the normal

process of CE marking.

If the systems and kits also contain products not classified as medical devices, these products go to follow the specific regulations for the sector.

As for active implantable devices (except for custom-made devices), according to egislative Decree 507/92 (and subsequent amendments) the manufacturer to affix the

CE marking of conformity to its product chooses one of the following:

1. procedure for the declaration of conformity (Annex 2: complete system of quality assurance)
2. procedures relating to the EC (Annex 3) together with:

* procedure relating to EC verification (Annex 4)
* procedure relating to the EC declaration of conformity to type (Annex 5: Quality assurance of production)



Active implantable devices tailored must have a manufacturer's declaration containing the information given in Annex 6.

Lgs. 46/97, Article 23 provides for penalties for non-compliance with the requirements stated above.In particular, manufacturers, paragraph 3 of the said states: "Whoever places on the market or put into use medical devices without the CE mark of conformity or is punished, unless the fact is provided as a crime, with pecuniary administrative sanction for payment of a sum of euros15493,71 /euros 92962,24. The same penalty applies to those who affix the CE marking or wrongly in such a way as to violate the prohibition in art. 16, paragraph 3 or Article 17, paragraph 8 - bis. "