Surgical medical devices (PMCs) may be marketed only after having being registered at the Ministry of Health in accordance with current legislation D.P.R. n. 392 of the 6 October 1998 and the Provvedimento of the  5 February 1999. 

In order to proceed with the marketing authorisation, the correct documentation must be submitted to the Ministry of Health and to the Superior Health Institute (ISS), in order to be carefully evaluated by both authorities.
The Presidi Medico Chirurgici thus authorised display on the label the sentences: “Presidio Medico-Chirurgico” and “Registrazione del Ministero della salute n. .....”

The Directive 98/8/EC of the European Commission and Parliament, implemented into the Decreto Legislativo of the 25th of February 2000 n. 174, regulates the marketing of Biocides and thus will substitute the present national legislation on the marketing authorisation of Presidi Medico Chirurgici.

Furthermore the active substances employed in the numerous products placed on the market before the 14th of May 2000, are currently under revision in order to keep only those substances that have a viable business and at the same time to standardize the European market.

However, by extending the period of revision until the 14th of May 2014 (Directive 2009/107/EC), the transition period from PMCs to Biocides has also been expanded. This period will be considered as concluded only when, after the above-mentioned date, the marketing authorisation of the products currently on market lapses.

Due to this period of transition, the active substances contained in the PMCs to be registered, must be part of the revision program (Annex II of the Directive 98/8/CE).
The “new” active substances (the ones which were not on the market before the 14th of May 2000), must be included in Annexes I and IA to be used for the preparation of biocidal products.

For the purposes of marketing a product with the characteristics listed above, or simply show a "biocide” activity, it is therefore necessary as a first step to check the status of the individual evaluation of the active ingredient.