The Council Directive 93/42/EEC and subsequent amendments and integrations, as per Italian legislative decree No. 46 dated 24 February 1997, which transposes this directive, applies for the placing on the market and launching of medical devices and their accessories.
It provides for documented procedures to identify, by appropriate means, the products from the receiving, all the way through the process until delivery and installation.
All products manufactured and/or placed on the market by LUMED are supplied with a lot number contains all the information necessary to allow traceability in accordance with the Council Directive 93/42/EEC.
The lot number is also shown on the commercial invoice and bill of lading.
It is therefore necessary a good organization to keep a traceability file towards your customers, in order to allow the withdrawal from the market to the occurrence of accidents in accordance with the Legislative Decree 46/97.
It is also required to distribute our products in the entire sales package without splitting the content, thus avoiding the consequent inability to keep information for a correct use and traceability.
It is also necessary to send LUMED any technical or commercial feedback on medical devices coming from end users.
Trusting in your cooperation to comply with the requirements of the directive, we invite you to take into consideration our request.