As someone said, an EU regulation is good for harmonizing the requirement across Europe, but be aware of the translations should you encounter different opinions from another Member State.
This book was mainly created to support German native speakers who work in an international environment.
Every word has a number of different meanings and let us hope that the translations capture the right term for its specific cause.
Just two examples:
(47) “clinical investigation plan means…, design, …”
47. „Klinischer Prüfplan bezeichnet … die Konzeption, …”
(f) “ …the design and performance data …”
f. „…der Auslegung und Leistungsdaten …“
As we know, the MDR was created in English initially and the other language versions were created upon that. The first translation delivered was heavily criticized by some member states and another round of translation was needed. This alone shows that differences may still exist and it may be beneficial to check another language version. In particular if you ask the question: "What was intended by the policymaker?" Bearing in mind the English version was the working document for most of them.
This document is helpful in some areas to quickly come to a conclusion in case of doubt of a certain requirement.
Good luck and indeed it is fun to explore the legal language in practical regulatory solutions. You will find at times interesting differences or even plain mistakes working with this on a daily basis.
Please leave your comment if you find discrepancies.
Important: This book is intended to be printed and used as your desk version to make your notes. The book is designed so that, when you print it using both side of the paper sheet, you will always have in front of you the English version (left side) and German version (right side), allowing you to make a direct comparison.
Of course, you can also decide to keep it as a digital document and use it as so.
In case you decide to print it, we recommend to test a couple of pages before printing the full document to ensure you have the right settings in you printer. Let's protect the environment!
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