Market-access intelligence for life sciences — a weekly scan of DE, AT and CH regulatory changes, with what each means for pricing, reimbursement and getting paid.
No new binding Austrian rule in this window. The lead German item is a G-BA decision of 15 October that was published after our last edition; everything else is dated 20–26 October.
Market-entry rules for new hospital methods change; the tender question goes to the Länder.
Implementing the GKV contribution-stabilisation act (BStabG), the G-BA amended its procedural rules. The early benefit assessment of new hospital methods (Section 137h SGB V) now covers any new method that is not based solely on a drug, triggered by a hospital’s first NUB request — not only methods using high-risk-class devices. Manufacturers that apply for a trial under Section 137e(7) must commission and pay an independent institution, including compensation for participating hospitals; if they do not commit to the costs within two months, the procedure stops. The change takes effect on the day after publication in the Federal Gazette, but not before 3 November 2026.
Why it matters: Lower-class devices behind a new hospital method can now be pulled into a G-BA assessment the first time a hospital files a NUB request. Plan evidence and budget for a possible manufacturer-funded trial before you encourage hospitals to request NUB funding. See how a NUB application works.
Sources: G-BA decision, 15 Oct 2026 (PDF)
The emergency-care reform passed by the Bundestag on 15 October needs Bundesrat consent. BVMed’s patient initiative “Faktor Lebensqualität” asks the Länder to call the mediation committee and strike the reintroduced tenders in Section 127(1c) and (1d) SGB V, or at least exempt sensitive care areas. The same carrier law also makes DiGA manufacturers carry more financial responsibility.
Why it matters: If the Bundesrat consents, statutory insurers can tender Hilfsmittel again. Keep tender pricing scenarios ready and watch the Bundesrat plenary agenda; DiGA makers should check the new cost rules in the final text.
Sources: PZ, 20 Oct 2026
Quiet for market access; the EUDAMED deadline is one month away.
The six-month transition after Commission Decision (EU) 2025/2371 ends around the end of November 2026, according to our reading of the BASG notice.
Why it matters: Austrian manufacturers and authorised representatives: complete EUDAMED actor and UDI/device registration now and confirm the exact date with BASG.
Sources: BASG notice
Electronic submissions and the SMS duty move closer.
Swissmedic released version 2.0 of the package for the Swiss Implementation Guide for eCTD v4.0. In July it said technical implementation should finish by the end of 2026, with go-live expected in 2027 after pilot testing.
Why it matters: Companies filing in Switzerland should get their publishing tools and vendors ready for eCTD v4.0 in 2027.
Sources: Swissmedic, 26 Oct 2026
From 15 November 2026, active substances must be registered in the EMA SMS database before they can be included in Swiss establishment licences and GMP certificates.
Why it matters: Check SMS entries for every active substance listed in your Swiss licences now.
Sources: Swissmedic, 1 Oct 2026
No plenary date has been confirmed; a law-firm update points to November as the indicative month for Parliament’s vote on the Council position.
Why it matters: No change to plans: keep the gap analysis on data protection and orphan exclusivity running.
We found no Council general approach on the Commission’s December 2025 proposal (broader clinical evidence, a larger EMA role); Parliament’s committee work continues.
Why it matters: Current MDR/IVDR transition deadlines (2027–2029) still apply; do not plan on relief until a text is agreed.
We advise life-sciences companies on pricing, reimbursement and regulatory strategy across Germany, Austria and Switzerland. Book a call to work through what these changes mean for your portfolio.
Book a session →Disclaimer. This digest is prepared by BCA (bcaun.de) for general information only and is not legal advice. Regulatory positions change quickly: every item marked Transition, Watch or In ratification is not settled law, and dates, scope and entry-into-force can shift. Confirm any such item directly with the competent regulator — BfArM, PEI, G-BA or GKV-Spitzenverband in Germany; BASG/AGES in Austria; Swissmedic in Switzerland; the European Commission or EMA at EU level — before acting. This edition covers 21–27 October 2026 and was issued on 27 October 2026.