Home > Search Results: keywords:"nařízení (EU) 2017"
Search:
Search Tips :: Advanced Search
Search collections:
Sort by: Display results: Output format:
National Repository of Grey Literature 1 records found  Search took 0.00 seconds. 
Free Movement of Medical Devices
 Moravová, Veronika ; Šmejkal, Václav (advisor) ; Svoboda, Pavel (referee)
1 Abstract This thesis deals with the conflict between the interest in the free movement of medical devices and the interest in the protection of health and safety. It is divided into two main parts, with the first part focusing on the pre-market phase, i.e. the phase before a medical device is placed on the market. The first part consists of two chapters describing the historical development of the regulation of medical devices and its separation from the regulation of medicinal products, as well as the way in which medical devices enter the market and what they must fulfil in order to be freely traded across the Member States. In particular, this part addresses the question of whether this separation (i.e. the move away from the 'old approach' to the 'new approach') was a step in the right direction or a 'historical mistake'. The system of CE certification of medical devices based on the participation of external auditors - Notified Bodies - is thoroughly discussed. The second part of the paper is devoted to the post-market phase (after the medical device has been placed on the market). The focus is on two 'knot problems', i.e. areas where the interest in free movement and the interest in protecting health and safety collide in practice, namely border products and parallel trade (specifically issues...
Detailed record

Interested in being notified about new results for this query?
Subscribe to the RSS feed.
Digital Repository :: Search :: Submit :: Personalize :: Help
Powered by Invenio v1.1.2
Maintained by admin.invenio@techlib.cz
This site is also available in the following languages:
Česky  English