24th May 2022, Microsoft Teams (Slovenian language)

Training in the field of medical devices: IMPACT OF THE NEW REGULATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDR) ON THE MANUFACTURE AND DISTRIBUTION OF IVD DEVICES AND LABORATORIES OF HEALTH INSTITUTIONS

The training is intended for manufacturers, authorized representatives, importers, distributors and vendors, included in the supply chain of in vitro diagnostic devices (IVD devices) and employees of laboratories of health care institutions who want to learn about the changes brought by IVDR and its obligations under the IVDR.

The knowledge gained will help you identify the gap between your existing way of doing business and the requirements of IVDR.

The knowledge and instructions gained during the training will give you the basis for:

• difference between IVD devices manufactured in accordance with IVDR or IVDD;
• to find out whether the IVD devices that you place on the market and use or make available on the market are manufactured in accordance with the requirements of the IVDR;
• to find out whether you use laboratory-developed tests (LDT) or house tests (IH-IVD) in your work and therefore you must meet certain conditions;
• to find out where you are classified as an economic operator according to the IVDR (among manufacturers, authorized representatives, distributors and / or importers) and what obligations you have to fulfill and what your responsibilities are;
• identify the appropriate tasks you need to perform to align your business with the IVDR;
• choosing the most optimal approach to establish IVDR compliance.

Click HERE for more information on the workshop.

Click HERE to apply for the workshop.