Biocides and Medical Surgical Aids

The Medical Surgical Devices, as required by Article 1 of Presidential Decree 392 of 6 October 1998, are the following:

• Disinfectants and substances marketed as germicides or bactericides
• Insecticides for domestic and civil use
• Insect repellents
• Rat poison for domestic and civil use

The national legislation controlling the placing on the market of these products will be completely replaced by the European legislation 528/2012 on biocides, thus leading to the integration of medical and surgical aids in the category of biocides. When the registration dossier is not being submitted within the deadline, the product must be being removed from the market, whether it is authorized as a medical-surgical device or a free sale product.

LabAnalysis Group offer consulting and testing services to place PMCs and biocides on the market:

• Definition of the strategy based on the asset (and the supplier) that is being used, the supply chain formula and based on the tests already available
• Product efficacy test for bactericidal and fungicidal activity (EN13727, EN1276, EN 1650) in accordance with GLP
• Product efficacy test for virucidal activity (EN14476) in accordance with GLP
• Chemical-physical assays according to OECD / CIPAC methods
• Accelerated and long-term stability test of the product in accordance with GLP
• Classification of the product through in-vitro toxicity and aquatic eco-toxicity studies in accordance with GLP
• Assessment of human risk and environmental risk following the use of the product
• Preparation of the documentation for the application and management of the Ministry's request