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.
A quiet week for formal legal changes: no new binding DE, AT or CH rules with a verifiable date in this window. The items below are news from 29 September–6 October plus still-pending deadlines, each with its date.
EUDAMED obligations are running, and the AMNOG reform is still waiting for a draft bill.
Use of the Actor Registration, UDI/Devices, Notified Bodies and Market Surveillance modules became mandatory on 28 May 2026. In Germany, registration runs through BfArM's DMIDS.
Why it matters: Manufacturers and authorised representatives need EUDAMED actor and UDI/device data in place. The six-month transition triggered by Commission Decision (EU) 2025/2371 implies roughly the end of November 2026 — our reading; confirm with BfArM.
Sources: BfArM: EUDAMED becomes mandatory · BfArM DMIDS FAQ
No new official step this week after the G-BA (16 Sep) and GKV-SV (18 Sep) statements on the Health Ministry's proposals. A draft bill text is still pending.
Why it matters: Keep dossier and negotiation planning flexible for orphan and conditionally approved products until a draft appears.
Sources: G-BA statement, 16 Sep 2026 (PDF)
BASG confirms the EUDAMED timeline for Austrian operators.
BASG confirms the first EUDAMED modules became mandatory on 28 May 2026, following Commission Decision (EU) 2025/2371 of 26 November 2025, which triggered a six-month transition under Regulation (EU) 2024/1860.
Why it matters: Austrian manufacturers and authorised representatives face the same end-of-transition date as in Germany. Confirm the exact deadline with BASG.
Sources: BASG notice
The HMG consultation enters its final days; the MRA is still a 2027-plus story.
The consultation on the Therapeutic Products Act (HMG) revision, opened on 19 June, ends on 16 October 2026. It includes a supervision fee on manufacturers and importers of medical devices.
Why it matters: Last chance to submit input, directly or through industry associations.
An industry source reports the updated MRA package, signed on 2 March 2026, needs consent from the European Parliament and Council and Swiss parliamentary approval — likely with a referendum — so entry into force is not expected before late 2027. Until then, CH-REP and EU authorised-representative requirements remain.
Why it matters: Do not drop CH-REP or EU-REP arrangements yet. Single secondary source — verify with the Federal Council or SERI.
Sources: MedDeviceGuide, 9 Jun 2026
A law-firm report of 30 September says the Council adopted the package on 28 September; Parliament adoption and Official Journal publication are pending, with entry into force after that. Application is expected around 2028.
Why it matters: Start the gap analysis on regulatory data protection, orphan exclusivity and supply obligations now — timing may shift. Confirm the stage on EUR-Lex.
Sources: Matheson: EU Council adopts new EU Pharma Package (30 Sep 2026)
The TUeV-Verband warned that moving medical devices from Annex I Section A to Section B of the AI Act would remove the direct application of high-risk AI requirements, and urged member states to keep full coverage.
Why it matters: AI-enabled devices and software could face a different compliance path. The question sits in the AI omnibus and the MDR reform talks and is unresolved.
Sources: Pharmazeutische Zeitung, 30 Sep 2026
The Commission published the first JCA report (Ojemda/tovorafenib, Ipsen) on 9 June 2026; 18 JCAs have been initiated since January 2025, mainly in oncology and ATMPs.
Why it matters: Member states are expected to use JCAs without adding their own requirements — align G-BA dossiers with JCA submissions.
Sources: European Commission news, 9 Jun 2026
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 29 September–6 October 2026 and was issued on 6 October 2026.