The difficult transition from Presidi Medico Chirurgici (Medical-Surgical devices) to Biocides is essentially due to the necessity of developing a European legislation, which properly regulates all those products belonging to the biocidal product classification. Disinfectants and products with a biocidal action are now subject to local regulations and thus differently regulated according to the country of interest. Once the implementation of the Directive 98/8/EC and subsequent regulations is completely in force, it will be possible to have a more effective control over the active substances and to facilitate product authorisations in the European market. With the Directive 98/8/EC, a ten-year programme of revision has been established in order to evaluate all the active substances present on the market before the 14th of May 2000, in order to identify and group those substances whose use in the preparation of biocides is considered appropriate. The regulations 1896/2000 of the 7th of September 2000, and 2032/2003 of the 4th of November 2003 as well as the 1048/2005/EC of the 13th of June 2005, go to regulate the phases of the review programme. According to the 1896/2000 legislation, the first phase of the programme regards the identification of active ingredients present in the market on May 14, 2000 (Date chosen according to Directive 98/8/EC of 14 May 1998 which provided two years to Member States for implementation at the national level) explaining the procedure to be followed for that purpose.

The regulation 2032/2003 regulates the second phase of the programme, by also listing the active substances to be evaluated. Any substance not included in the first phase of review, is to be assessed as a "new substance".

The final regulation sets out the terms for a chance to extend the deadline for marketing in the cases where the products contain active ingredients of "essential use". The above mentioned regulations have subsequently been modified by the regulations 1849/2006 of the 14th of December 2006, the 1451/2007 of the 4th of December 2007 and the 298/2010 of the 9th of April 2010, which further regulate the second phase of the revision programme and introduce some changes regarding, for example, the extensions for “essential use” and for biocide marketing authorisations. The active substances undergoing the revision programme and those selected because of a positive evaluation have been grouped together in specific annexes of the Directive 98/8/EC, constantly updated by decrees of inclusion and exclusion:

Annex I (containing all the active substances considered as suitable for the preparation of biocidal products)
Annex IA (with the non dangerous active substances which can be used for the preparation of  “low risk biocidal products”)
Annex IB (listing the “basic substances” which are defined as the substance “whose major use is non-pesticidal but which have some minor use as a biocide either directly or in a product”)
Annex II (containing all the substances still under revision)

Following the Directive 2009/107/EC, the revision programme has been extended until the 14th of May 2014, to allow the completion of the review programme.   
This situation leads to a transition period, in which the national legislations regulating the placing of biocidal products on the market overlap the European directives. According to this directive, it is possible to authorise the marketing of a product by following the national legislation only when the active substances employed are part of the Annex II, are not included in the Annexes I and IA and have not been excluded from these annexes with a specific decree of exclusion. When the active substances are registered in the Annexes I or IA, the product has to be authorised as a biocide. Finally, if only one of the active substances is not included in the Annexes I or IA, the product cannot be authorised as a biocidal product. Therefore, the registration of a PMC (Medical-Surgical Device) in Italy is only possible for a product containing an active substance registered in the Annex II for the PT of interest and this authorisation is effective until the date of inclusion of the active substances in the Annexes I or IA.

Products containing active substances excluded from the Annexes I or IA with a specific decree or for which no evaluation has been required by a Member State before the 14th of May 2014, are automatically excluded from the market. In order to obtain the marketing authorisation, it is thus necessary to firstly evaluate which active substances are usable for the preparation of biocidal products and which PT can be considered for each active substance.