Conformity assessment for medical devices of I class and medical devices for in vitro diagnostic, categorized as ‘others’.

Details:

• 
  Date: January 24 2021, Friday
• 
  Time: from 09:30 up to 13:00
• 
  Event adress: Baggovutovskaya str. 17-21, 6th floor, 04107, Kiev, Ukraine
• 
  Language of the event: Ukrainian
• 
  Speakers:

  • Anna Hnatiuk
  • Alla Somyk
• 
  Cost:

  • 1200.00 UAH (VAT is not included)

In the event:

1. How to classify medical devices of I class and medical devices for in vitro diagnostic, categorized as ‘others’?
   Whether risk class of devices depends on its scope of use. Borderline products.
2. List of necessary documentation. Storage of documentation by Authorised representative: timelines, form etс.
3. Conduction of conformity assessment procedure.
4. MOH Order №122 on maintenance of Register of persons, responsible for introduction of medical devices. Entering in the Register. Specific requirements and the most frequent observations.