1 Sep 2026
Summer 2026 round-up — DE, AT & CH
GKV-BStabG (DE) in force; swissdamed mandatory and EU–Swiss MRA still unratified (CH); CMDh guidance updates (AT); EU JCA reaches high-risk devices.
Read edition →A weekly scan of pharmaceutical and medical-device regulatory changes across Germany, Austria and Switzerland — pricing, reimbursement, clinical trials and device rules — with what each change means for market access. Every edition is archived below.
Germany's GKV-BStabG in force from 30 July 2026 (tighter AMNOG, DiGA restructuring); Switzerland's swissdamed device registration mandatory from 1 July 2026 while the EU–Swiss MRA stays unratified; and EU Joint Clinical Assessment reaching high-risk devices in 2026.
Read the edition →GKV-BStabG (DE) in force; swissdamed mandatory and EU–Swiss MRA still unratified (CH); CMDh guidance updates (AT); EU JCA reaches high-risk devices.
Read edition →We translate DE / AT / CH regulatory shifts into what they mean for your market access — pricing, evidence and the path to getting paid.
Book a session →Each edition is a general, non-exhaustive summary of publicly reported developments at its issue date and is not legal or regulatory advice. Items may be in transition or ratification; confirm the current position with the relevant authority (BfArM/PEI, G-BA, BASG/AGES, Swissmedic, the European Commission/EMA) and qualified counsel before acting.