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.
The week was dominated by the "AMNOG 2.0" reform debate: the BMG concept drew formal statements from the G-BA and the statutory insurers, and a Section 137h timing point was confirmed.
The G-BA chair published a formal Stellungnahme on the Health Ministry's proposed reform of the early benefit assessment ("AMNOG 2.0"). The BMG concept would let medicines with a special regulatory status — PRIME, Accelerated Assessment, Conditional Marketing Authorisation or approval under exceptional circumstances — regularly receive a positively quantified added benefit even where the evidence base carries elevated uncertainty, and treat a pivotal-study primary endpoint as "provisionally" patient-relevant. The G-BA underlined the value of the current procedure's transparency.
Why it matters: If enacted, this reshapes the added-benefit calculus for conditionally-approved and accelerated products — potentially a better German outlook for early-access assets, but with more contested comparators and price negotiations downstream. Model both the current and reformed rules for any asset on a PRIME or conditional path.
Two days after the G-BA, the GKV-Spitzenverband — the payer body that negotiates the Erstattungsbetrag — filed its own statement on the AMNOG 2.0 regulatory draft.
Why it matters: The payers' position is the counterweight that decides how much of the reform survives. Statutory insurers rarely favour an automatic added-benefit for uncertain evidence, so expect pressure to narrow the concession — watch the gap between the BMG concept and the final text.
Reporting this week confirmed that the widened G-BA assessment of new examination and treatment methods relying on high-risk devices (Section 137h SGB V) takes effect only after 31 October 2026.
Why it matters: Medtech companies whose hospital-access route runs through Section 137h should time their method notifications and NUB planning around the new start date and the broader scope — and factor the assessment into launch sequencing.
Sources: G-BA — latest resolutions
No change this week to the EU device-registration timeline: devices placed on the market before 28 May 2026 must be registered in EUDAMED by late November 2026. As at this issue, the deadline has not moved.
Why it matters: Unregistered legacy devices face market-availability and enforcement exposure from December. Confirm the exact date (27 vs 28 November) with BfArM where it matters commercially.
Sources: BfArM — EUDAMED
Another quiet week in Vienna: no Erstattungskodex change and no device-registration rule moved between 16 and 22 September.
We found no new Austrian legislation, BASG/AGES policy change or Erstattungskodex development dated to this window — BASG activity was routine market surveillance. The items that matter for Austria are EU-level and carried forward below.
Why it matters: Nothing to action for Austria specifically. The live watch items — the EU pharma package, the MDR/IVDR revision and the EUDAMED deadline — all apply to Austria once effective, so track them there too.
Sources: BASG — home / official announcements
Guidance housekeeping from Swissmedic this week, against the run-up to the year-end swissdamed and ElViS 2.0 deadlines.
Swissmedic revised the routing and the Q&A on mobile technologies, and specified the requirements for the use of QR codes on medicine packaging.
Why it matters: Digital-health, connected-product and packaging teams selling in Switzerland should check the updated expectations before finalising artwork or a companion app — QR-code and mobile-technology requirements are easy to miss and awkward to retrofit.
Sources: Swissmedic — new on this website
Swissmedic issued, for the first time, an FAQ on enforcement practice for the revised Fees Ordinance (FeeO-Swissmedic), explaining how it charges fees. The list currently holds three questions and will be expanded.
Why it matters: Useful when budgeting the new swissdamed device-registration fee (CHF 200 first product, CHF 20 per additional, capped at CHF 10,000/year) and the raised hourly rate. Fold it into your Swiss compliance cost line.
Sources: Swissmedic — Fees Ordinance revision
No movement this week on either year-end deadline: the ElViS 2.0 vigilance switch to E2B(R3) is set for 21 December 2026, and the swissdamed device-registration transition closes 31 December 2026.
Why it matters: Both land in the holiday period. MAHs and device makers should complete the ElViS changeover and any outstanding swissdamed registrations before mid-December, not at the deadline.
Sources: Swissmedic — swissdamed registration
The EU's Joint Clinical Assessment programme continues to expand: 15 JCAs have been initiated under the 2026 HTACG work programme, which for the first time brings selected high-risk medical devices into scope. Last week's SMA advanced-therapy JCA report is already running alongside a live German AMNOG procedure for the same indication.
Why it matters: For any ATMP or oncology asset in JCA scope, the EU clinical conclusions and the German Section 35a dossier are now being built on overlapping evidence — align comparators and PICO across both to avoid a self-inflicted divergence.
No plenary adoption of the EU pharmaceutical package was confirmed in the sources reviewed for this issue. COREPER endorsed the trilogue texts in March 2026; final European Parliament and Council approval remains targeted for autumn, with entry into force 20 days after Official Journal publication once adopted.
Why it matters: Data-protection duration, the antimicrobial voucher and the revised Bolar/HTA interface reshape launch sequencing in Germany and Austria — but nothing applies until publication, so keep it out of firm 2027 plans for now.
Sources: Council — the pharma package
The Commission's proposal to simplify the MDR and IVDR and adjust select deadlines (published December 2025) continues through accelerated co-decision; no final adoption is confirmed as of this edition.
Why it matters: The revision aims at lighter administrative burden and more proportionate conformity assessment for lower-risk devices — but none of it is law yet. Keep certification planning on the current MDR/IVDR and use the autumn technical meetings for industry input.
Sources: European Commission — medical devices, new regulations
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 16–22 September 2026 and was issued on 22 September 2026.