31.1 Introduction

The European Directive for in vitro diagnostic (IVD) medical devices (IVDD 98/79/EC), which became operational in Member States by December 1998, was implemented in Italy in September 2000.

This Directive introduced common requirements in order to establish a uniform level of safety, quality, and performance of IVD devices. Thus since 1998, the Directive began circulation in the European Community, and therefore also in Italy, of IVDs compliant with the Directive and bearing the European Community marking (CE).

The Directive applies to IVD reagents, reagent products, calibrators, and instruments, including specimen containers, intended by the manufacturer to be used in vitro for the examination of samples from the human body, including tissues, blood, or other fluids, in order to provide information on the state of health of the patient.

The Italian Legislative Decree of 8 September 2000, n. 332 “Implementation of Directive 98/79/EC on in vitro diagnostic medical devices” includes the basic concepts underlying the Directive itself and the need to adopt measures to enable the free circulation within the European Community of goods, persons, services, and capital as follows:

1. the need to provide for certification procedures and control of IVD medical devices at the community level, to ensure the security, health protection, and operation of the devices that do not hamper trade within the European Community;
   
2. the need to harmonize national provisions on safety and health protection of patients, users and any third party interested in the use of IVDs and to ensure the free movement of such devices in the EU;
   
3. the need for IVD medical devices to ensure a high level of protection for patients, users, and third parties.

All these concepts entailed a major revision of the rules that previously prevailed in Italy: in fact, until the Implementation of Directive 98/79/EC, a system for the authorization and licensure regulation was provided only for IVDs for the diagnosis of hepatitis and of HIV, while the Legislative Decree n. 332 led to a system of certification and quality assurance based on specific procedures.

These procedures relate to the complexity and sensitivity of different products, involved appropriate governmental agencies, designated by the competent governmental authority (Ministry of Health), which grant the verification of compliance of in vitro diagnostic technical requirements as specified in the Directive.

31.2 National classification of medical devices

The National Commission of Medical Devices (CUD) was established by the Italian Finance Act 2003 (Art. 57, Law 27 December 2002, n. 289) with the task of defining and updating the repertoire of medical devices and to classify all products into classes and subclasses. The CUD defined the first national classification of medical devices (CND) (approved by the Italian Ministerial Decree of 22 September 2005).

The IVD medical devices, although falling within medical devices, were not included in the first draft of the CND. The CUD, nominated for the biennium 2005–2007, decided to proceed with a modification of the first version of the CND and complete it by including also the IVD medical devices not included in the first version. The updated version of the CND was approved by the CUD on November 29, 2006. The decree February 20, 2007 “Approving the National Classification of Medical Devices (CND)”, defined by the Ministry of Health in agreement with the State-Regions Conference, is published in the Official Journal (OJ) of the Italian Republic (similar to the Code of Federal Regulations, CFR, in the United States) n. 63 of March 16, 2007. The CND and subsequent updates are also published in the OJ, as well as in the portal of the Ministry of Health. The new CND in accordance with the guidelines for classification already defined in the first version and only partly expanded in the latter, has an alpha numeric structure that aggregates medical devices in “Categories”, “Groups”, and “Types”. The types reach different levels of detail.

All IVD medical devices were included within the CND in the specific category of “W”, which were classified by adopting the system in general classification proposed by the European Diagnostic Manufacturers Association (EDMA).

Diagnostic reagents were included in the group “W01” divided into the following types:

• W01 01: Clinical chemistry
  
• W01 02: Immunochemistry
  
• W01 03: Hematology/Histology/Cytology
  
• W01 04: Microbiology
  
• W01 05: Immunology of infectious diseases
  
• W01 06: Genetic tests.

The classification proposed by the EDMA has been further developed into the following groups:

• “W02” for Instrumentation IVD
  
• “W05” for IVD storage devices and supplies for general use.

In the Italian territory, entry is allowed into the market of IVD medical devices if it bears the CE mark to demonstrate compliance with law 332/2000 (Implementation of Directive 98/79/EC).

To receive the CE mark, any IVD medical device must meet the “essential requirements” set out in Appendix I to Legislative Decree 332/2000. Compliance with the essential requirements means that the devices are suitable for the established diagnostic purposes and have been designed and manufactured taking into account the generally recognized state of the art, so that their use does not compromise the health and safety of patients and users. Any risks relating to the use of the diagnostic device must be identified and brought to an acceptable level that must be demonstrated with the analysis of risks. These devices must achieve, where appropriate, acceptable performance particularly in analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, and reproducibility, including control of known relevant interference and limits of detection.

Conformity assessment procedures are described in relation to the type of device: the different procedures are applied so as to be proportionate to the degree of potential risk based on the negative effect that could be produced when the medical device in vitro fails.