Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The European MDR and its potential impact on the existing German legislation on medical devices and the status of the discussion on the interpretation of several requirements of the MDR

Susanne Werk (Abschlußjahr: 2019)

Summary
Language: English
The MDR (Medical Device Regulation (EU) 2017/745) was adopted on 5 April 2017 and entered into force on 25 May 2017. Although it is a regulation some experts state that it has more the character of a directive as there are some items which need further clarification or guidance before the procedures requested in the MDR may be realisable.
There are implementing and delegated acts which need to be adopted by the EU commission. The new EUDAMED (European Database on Medical Devices) and UDI (Unique Device Identification) system need to be set up by the EU commission as well as the MDCG (Medical Device Coordination Group) and expert panels.
Each national legislator needs to adapt their national legislation on medical devices as some parts will still be applicable.
This thesis reviews the German legislation on medical devices and asks how this might be adopted now and collects open questions from involved parties on the requirements of the MDR.
Pages:44