“In vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
– concerning a physiological or pathological state
– concerning a congenital abnormality
– to determine the safety and compatibility with potential recipients
– to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
B. CE MARKING APPLICATION
For the application of the CE marking on in vitro medical devices, Companies should complete a technical dossier containing the following information:
– general description, including any planned variants; – quality system documentation;
– design information;
– information about the origin and collection modality of the same of the devices if they contain human tissues or their derived substances;
– description and explanations necessary to understand characteristics, drawings and diagrams of the working product;
– risk analysis results;
– if products are sterile, with a special microbiological or cleanliness state, description of used procedures;
– calculations results of the plan, of carried out inspections, etc..;
– if the device must be connected with one or more other devices, that have characteristics specified by the manufacturer, it must be checked for compliance with the essential requirements of the first device;
– test reports;
– performance evaluation data;
– labeling and instructions for use;
– stability studies results.
Manufacturer shall take necessary measures to ensure that the manufacturing process follows quality assurance principles.
Quality system consists of:
– organizational structure and responsibilities;
– manufacturing processes and systematic quality control of production;
– devices traceability;
– performance quality system checks.
C. CONSULTING PROCEDURE
Qua.Ser. Ltd provides for following assistance activities:
– asking for information to Companies to compile a first draft of technical file;
– writing a first technical draft;
– visit to Companies to acquire necessary information to prepare the final draft of the dossier;
– delivery of the technical dossier and the Quality Assurance Manual to the Notified Body (if applicable, depending on the type of product).
Then Notified Body, Company’s representative and Qua.Ser Ltd. official, discuss content of the technical file.
Any non-compliance found by Notified Body will be reviewed by Qua.Ser Ltd without any charge to Customer.
Assessment visit by Notified Body Inspector at establishments of production, with assistance of Qua.Ser. Ltd.
Issue of Certificate and CE Marking.