Ukrainian Scientific Institute of Certification

The workshop «New medical device and in vitro diagnostic medical device EU Directive» was held on April 12, 2019


At the end of 2018, UNI-CERT staff went through a course of new EU Directives in the Lloyd’s Register Quality Assurance (LRQA) Notified Body (London, UK) and, together with the Association of market operators of medical devices (AMOMD), conducted a workshop on “New In Vitro Diagnostic Device and Medical Device EU Directive” on April 12, 2019.

The following topics were covered in the course of the workshop:

  • peculiarities of the transition period, placing on the market of medical devices using the “Old” Medical Device Directive (MDD) certificates;
  • changes in the classification and definition of In Vitro Diagnostic Devices and Medical Devices;
  • conformity assessment procedures under the “new” Directives;
  • new requirements for Technical Documentation and Quality Management System;
  • high standards for the quality and safety of medical devices, risk analysis;
  • new labeling of medical devices, including the Unique Device Identification (UDI);
  • new timelines for reporting incidents and increased post-market surveillance requirements;
  • effects of Brexit for EU notified bodies.

The effects of the “new” Directives on the technical regulation system in Ukraine has been assessed, and the possibility of EU certificate recognition in Ukraine issued under the “new” Directives has been discussed.

Photo report here