Germany strengthens medical data governance – what it means for life science
On 11 March 2026, the German Federal Cabinet adopted the draft Medical Register Act (Medizinregistergesetz), introducing a uniform legal framework for medical registries and the use of high-quality real-world data.
For manufacturers, CROs and regulators, this is a significant development:
- More reliable real‑world evidence (RWE) to support clinical evaluation, post‑market surveillance and benefit–risk assessments
- Clearer legal certainty for data use, including defined quality, security and data protection requirements
- Improved conditions for care‑related research, innovation assessment and patient safety
- New opportunities for cross‑registry collaboration and data linkage, enabling deeper insights into real‑world performance
At Aurevia, we see this as an important step towards closer alignment between clinical research, regulatory decision making and real-world healthcare data. As regulatory expectations around RWE continue to grow across Europe, structured and quality-assured registries will play an increasingly central role – supporting robust safety and performance evidence across the product lifecycle.
This is especially important for industry professionals and researchers since well-governed registries will make it easier for you to access high-quality data that strengthens clinical evidence on safety and real-world performance.
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