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The “new” Art. 10a MDR

The new Article 10a of the Medical Device Regulation (EU) 2017/745 (MDR) has been in force since January 10, 2025. The regulation entails comprehensive information obligations for all economic operators in the medical device sector. The aim of the regulation is to identify potential supply bottlenecks for certain medical devices at an early stage and...

Reading time: 3 min

Medical device law, pharmaceutical law, healthcare

Medical device law: Are changes to the Medical Device Regulation imminent?

Calls from politics and industry for further amendments to the MDR are getting louder and louder, which is why we would like to summarize the current discussion below. A brief overview of current developments The Medical Device Regulation (MDR), which has been in force since May 2021, continues to pose major implementation problems for the...

Reading time: 3 min

Medical device law, pharmaceutical law, healthcare

Hospital reform 2024: What funds and financiers need to know now

The traffic light coalition is planning to reform hospital care. The federal and state governments agreed on key points on July 10, 2023. Of the 16 states, 14 voted in favor. Schleswig-Holstein abstained and Bavaria voted against. The starting point for the key points paper is the preliminary work from North Rhine-Westphalia. Federal Health Minister...

Reading time: 5 min

Medical device law, pharmaceutical law, healthcare

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