Eastern Europe Market Access


This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).

  • Course Type: Video Lecture
  • Language: English
  • Level: Beginner
  • Session: year 2020
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:07:28
Bulgaria 00:01:08
Czech Republic 00:00:58
Hungary 00:01:02
Poland 00:01:03

Exam and Certifications

  • Final Test – Eastern Europe Market Access
  • Certification


What I will learn?

You will learn about applicable regulations and medical device registration in countries in Eastern Europe, along with country specific requirements including: legislative framework and procedure for approval

Skills I will gain

You are going to explore how the main requirements of the Medical Device Regulation, will be implemented in Eastern EU countries:

  • Bulgaria
  • Czech Republic
  • Hungary
  • Poland
  • Romania
  • Slovakia


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