Rechtsanwältin (Lawyer)
Francesca Pisacane has been working as a lawyer in our Freiburg office since 2024. She primarily advises clients in the areas of medical device law and commercial law.
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legal insights
22. August 2025
Attribution of fraudulent conduct by a testing company in the context of the conformity assessment procedure
If a manufacturer of personal protective equipment within the meaning of Article 3 of Regulation (EU) 2016/425 (PPE Regulation) engages a testing company as part of the conformity assessment procedure for its products, it must accept responsibility for any fraudulent conduct on the part of that testing company. This has been decided by the ruling...
Reading time: 3 min
Trade and Distribution Law
firm news
24. March 2025
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...
Medical device law, pharmaceutical law, healthcare
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