Talk:Germany/@comment-62.96.138.82-20200703142839

The article gives a great overview of the situation in Germany. Below are two reflections on “adaptation acts also for regulations” as well as on “stakeholder involvement”.

EU regulations are directly binding in the member states (MS) of the EU. Nevertheless, EU regulations may also require legislative activity at MS level, for example to prevent legal contradictions, to make technical adjustments or to use given opportunities for supplementary regulation/measures. A current example in Germany is the medical devices law: The European Union introduced the Regulation (EU) 2017/745 on medical devices (MDR). In Germany, there has been considerable legislative activity to adapt to the new EU rules, although the regulation is directly binding. The main national law calls “Law on the alignment of Medical Device Law to Regulation (EU) 2017/745 and Regulation (EU) 2017/746” (Medizinprodukte-EU-Anpassungsgesetz) which was submitted by the Bundesregierung and adopted by the Bundestag and Bundesrat in 2019, before the originally foreseen application date of the MDR in may 2020.

As mentioned in the article, in Germany, the transposition of EU law follows similar rules as the national policy making. In the national policy making various stakeholders officially have the opportunity to express their views during the policy making process (§ 47, Gemeinsame Geschäftsordnung der Bundesministerien). Against this background, stakeholders also give their opinions on laws that serve to transpose, implement and adapt to EU law, for example, more than 40 opinions were issued on the above mentioned national “Law on the alignment of Medical Device Law to Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.