The SARS-CoV-2 virus pandemic has brought up to date the regulation that controls the production of PMC, which has undergone several changes over the years.
The Medical Surgical Devices, as required by Article 1 of Presidential Decree 392 of 6 October 1998, are the following:
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:
For further information on Biocides and Medical Surgical AidsContact Us