European Commission's Lalis promises changes to address regulatory fragmentation

Executive Summary

Creating "a more stable and predictable regulatory framework" for medical devices is a key priority for Georgette Lalis, director at the Commission's Directorate General Enterprise and Industry, with oversight for medical devices and pharmaceuticals. To achieve this, Mrs Lalis and her team are looking at a range of stricter legal instruments than have historically been used for medical devices to ensure a more homogeneous implementation. Regular use of comitology to implement decisions and the possible reinforcement of the "meddev" guidance documents are now on the agenda for the woman who is on charge of regulations for five categories of consumer goods within Directorate F.