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.
After Council adoption, the EU pharma package awaits Parliament approval and Official Journal publication; the TUeV-Verband warns against an AI Act carve-out for medical devices; and the Swiss HMG consultation (16 Oct), EUDAMED transition (~28 Nov) and swissdamed (31 Dec) deadlines approach.
Read the edition →EU pharma package: what is left after Council adoption; TUeV-Verband warns on an AI Act carve-out for medical devices; EUDAMED transition confirmed by BfArM and BASG; Swiss HMG consultation closes 16 October.
Read edition →Council adopts the EU pharma package; G-BA and GKV-SV push back on the BMG's AMNOG reform; GKV-BStabG rebate rises to 15.5% from 2027; MDR/IVDR revision timeline; Swiss HMG consultation and swissdamed deadline.
Read edition →"AMNOG 2.0" reform draws G-BA and GKV-SV statements; expanded Section 137h starts after 31 Oct; Swissmedic updates mobile-technology, QR-code and fee guidance; EUDAMED and swissdamed deadlines close in.
Read edition →First EU JCA output (SMA gene therapy) runs alongside Germany's AMNOG track for Itvisma; Swissmedic's swissdamed device-registration fee goes live; G-BA opens a cochlear-implant reimbursement comment procedure; digoxin/digitoxin shortage declared.
Read edition →Seven-resolution G-BA AMNOG batch (exa-cel registry set aside, inebilizumab, mepolizumab COPD, oncology combos); EUDAMED legacy deadline ~11 weeks out; Swissmedic ElViS 2.0 and RP guidance; first EU JCA report sets the template.
Read 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.