WHAT DOES BEING A MEDICAL AND SURGICAL DEVICE MANUFACTURER ENTAIL?
Medical and Surgical Device is a particular category of products defined by Italian regulations, to be precise by article 1 of Italian Presidential Decree n. 392 of 6 October 1998.
According to this decree, Medical and Surgical Devices category includes disinfectants and germicides/bactericides, insecticides for domestic and civil use, insect repellents and rodenticides for domestic and civil use.
Considering that this type of product can potentially cause harm to people and the surrounding environment, their manufacture is heavily regulated.
The main active ingredients used must be included on a list drawn up on a European Community level that contains not only the substances authorised, but also the conditions for their use. There are currently 23 types of biocides, organised into 4 groups.
The products commercialised also have to carry a special label that indicates both the type of Medical and Surgical Device and whether it is a disinfectant or a biocide, and another label displaying the product registration number issued by the Ministry of Health.
Medical and Surgical Devices can only be manufactured by companies with Ministry of Health authorisation, defined as Medical and Surgical Device Manufacturers.
As well as this authorisation, companies carrying out this activity must also provide the Ministry of Health with technical documentation regarding the products before they can be released on the market, containing information regarding the identity of the active ingredient, its properties, safety assessments for people and the environment, and its effectiveness as a biocide.
All of these measures guarantee product effectiveness, people’s health and environmental protection.
IGO has been recognised as a Medical and Surgical Device Manufacturer with Medical and Surgical Device decree n. 28/2004 dated 09/08/2004, meaning it has more than 15 years’ experience in biocide manufacture.
The entire IGO production chain is certified, from the mixing of active components with solvents and fragrances to impregnation and the application of compounds onto a range of evaporation substrates, right up to the final packaging of products ready for sale.
Find out more about our complete service for the contract production of biocides.
