1st, 2nd & 3rd December 2021
Microsoft Teams (Slovenian language)
Regulatory 3-day online workshop on medical devices:
GOOD PRACTICES TO MEET THE REQUIREMENTS OF NEW LEGISLATION IN THE FIELD OF DISTRIBUTION AND IMPORT OF MEDICAL DEVICES
The workshop is aimed at all economic operators (distributors, sellers, importers, authorized representatives and manufacturers) of medical devices involved in the supply chain of medical devices and wishing to acquire relevant knowledge of the obligations for distributors and importers as set out in the MDR/IVDR regulations, together with practical guidelines and frameworks based on good distribution practice and established standards for quality managements systems that they can use to meet these obligations.
The workshop will enable you to determine to what extent you have already met the MDR/IVDR requirements and what needs to be adjusted and what new documented procedures and records need to be implemented. Filling the identified gaps with appropriate activities and processes will ensure:
- meeting the new requirements for storage, distribution and import of medical devices;
- optimal and appropriate documentation of procedures and records keeping;
- effective verification of the EU declaration of conformity, CE marking, labelling and instructions for use, importer data and unique device identification (UDI) based on a sampling method representative for the medical devices you supply;
- ensuring storage and transport conditions in accordance with the conditions laid down by the manufacturer;
- appropriate notifying of the manufacturer and the competent authority regarding medical devices that do not comply with the MDR/IVDR and may cause a serious risk (vigilance);
- adequate traceability of medical devices;
- appropriate evidence of compliance with the requirements of MDR/IVDR in the event of an inspection.
Click HERE for more information on the workshop.
Click HERE to apply for the workshop.