We are delighted to share our chapter in the seventh edition of Healthcare Enforcement and Litigation. The chapter provides an overview on the legal framework of healthcare enforcement responsibilities in the EU, outlined by our lawyers Ulrich Grau, Tobias Volkwein, Frederik Schoenen and Tatjana Teterjukow.
The legal framework of healthcare enforcement responsibilities in the EU, has to be separated between the statutes for pharmaceutical products and the ones for medical devices. Given the different regulatory approaches to both categories, the regulation of pharmaceutical products is deeper than the one for medical devices. However, in both fields the competences and responsibilities are primarily at member state level, with European authorities having mainly a more coordinative role.
Read our whole chapter here: