The launch of an administrative procedure aimed at verifying the existence of the conditions for maintaining the validity of the marketing authorizations as medical surgical aids (article 2 of the Presidential Decree 6 October 1998, n.392) of the products intended for disinfection is communicated of intact skin before medical treatment, since, according to the interpretation uniformly adopted at European level, these products fall within the scope of application of specific legislation incompatible with the definition of medical surgical aid.
For this reason, it is preliminarily noted that disinfectant products simultaneously fall both within the scope of application of the national legislation on medical and surgical devices (Presidential Decree No. 392 of 6 October 1998), and within the scope of application of the provisions on biocidal products ( EU Regulation 528/2012 of the European Parliament and of the Council of 22 May 2012).
Taking into account the partial overlap of the two regulations, Article 89 of Regulation (EU) 528/2012 provides for the transition from the national authorization regime for surgical medical devices to the European authorization regime provided for by the same Regulation, according to the timing set out in the aforementioned article .
In this regard, the orientation expressed at European level provides for the classification of disinfectants intended for use on intact skin before medical treatment in the context of medicinal products; this orientation, in addition to being an obstacle to the possibility of authorizing the placing on the market of the same as biocidal products pursuant to Regulation (EU) 528/2012, appears incompatible with the hypothesis of maintaining the relative authorizations in place as medical surgical devices pursuant to of the Presidential Decree 392/98. If, at the end of the investigation, this interpretation is confirmed, with the need to revoke the current marketing authorizations as a medical surgical device, the possibility of granting a transitional period of validity of the same on the basis of the procedure will be evaluated of the starting assumptions described in the notice of initiation of the procedure.
All interested parties are invited to submit, within 30 days from the date of publication in the Official Gazette of the notice, any observations, briefs or documents deemed relevant for the purposes of the procedure by certified e-mail to the address dgfdm@postacert.sanita.it .
Source: Italian Ministry of Health
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