Regular workshop on the regulation of medical devices: COMPLIANCE CHECK BEFORE MAKING MEDICAL DEVICES AVAILABLE ON THE MARKET

On 30/09/202402/10/2024In Current educations and trainings

28th November 2024, Ljubljana

Regular workshop on the regulation of medical devices: COMPLIANCE CHECK BEFORE MAKING MEDICAL DEVICES AVAILABLE ON THE MARKET (Slovenian language)

Our regular workshop is intended for everyone who wants to acquire basic knowledge or improve their competences in the field of checking compliance with requirements before making medical devices (hereinafter referred to as devices) available on the market, which is crucial for importers and distributors and represents an important requirement according to Regulation 2017 /745/EU on medical devices (MDR) and Regulation 2017/746/EU on in vitro diagnostic medical devices (IVDR), which is a necessary part of inspection control.

The knowledge acquired and the checklists you receive at the workshop will ensure you:

✓ optimal fulfillment of the compliance check obligation before enabling accessibility in accordance with the MDR and IVDR;

✓ practical knowledge to check:

  • equipment with a CE mark;
  • whether the manufacturer has prepared an EU declaration of conformity;                
  • whether the manufacturer is known and has appointed an authorized representative;            
  • information provided by the manufacturer;   
  • data of the importer;                                                                                                                                             
  • whether the manufacturer has determined the UDI, and                                    
  • certificate;

✓ establishing an appropriate representative sampling method to optimize the number of checks for the gadgets you distribute;

✓ adequate evidence of compliance with the requirements for checking before making the accessories accessible in the event of an inspection.

Click HERE for more information on the workshop.

Click HERE to apply for the workshop.