Regulatory Tracker

Regulation (EU) 2017/745

EU framework governing the placing on the market and conformity of medical devices. A targeted MDR/IVDR simplification revision (COM(2025) 1023) is before Parliament and Council.

• 2021-05-26: Date of application
• 2025-12-16: Targeted MDR/IVDR simplification proposed (COM(2025) 1023)
• 2026-05-28: EUDAMED first four modules mandatory (Reg (EU) 2024/1860)
• 2027-12-31: Class III, IIb implantable legacy transition ends (conditional)
• 2028-12-31: Class IIb non-implantable, IIa, Is, Im legacy transition ends (conditional)

• EU MDR Compliance for Swiss MedTech: The Dual-Track Reality
• Swiss Authorized Representative Requirements Under EU MDR/IVDR
• Clinical Evidence for SaMD: Regulatory Expectations
• Post-Market Surveillance for SaMD: When Software Keeps Changing

SR 812.213

Swiss medical devices ordinance, aligned with but distinct from the EU MDR; legacy-device transition periods mirror EU Reg 2023/607 since November 2023.

• 2021-05-26: Entry into force (revised)
• 2023-11-01: Transition-period alignment with EU Reg 2023/607 in force

• Swiss MedTech Export: Navigating Third-Country Status

Signed 2 March 2026; ratification pending

Signed treaty package updating the CH-EU bilateral framework. The revised MRA chapter on medical devices takes effect on ratification and would end Swiss MedTech's third-country status under the MDR.

• 2026-03-02: Package signed
• 2026-03-13: Botschaft adopted by the Bundesrat

• Swiss MedTech Export: Navigating Third-Country Status

Regulation (EU) 2017/746

EU framework for in-vitro diagnostic medical devices. Transitional periods restructured by Regulation (EU) 2024/1860; a targeted MDR/IVDR simplification revision (COM(2025) 1023) is before Parliament and Council.

• 2022-05-26: Date of application
• 2025-05-26: QMS-in-place condition for extended transition
• 2025-12-16: Targeted MDR/IVDR simplification proposed (COM(2025) 1023)
• 2027-12-31: Class D legacy transition ends (conditional)
• 2028-12-31: Class C legacy transition ends (conditional)
• 2029-12-31: Class B & sterile Class A legacy transition ends (conditional)

• Software as a Medical Device (SaMD): Classification Pitfalls

SR 812.219

Swiss in-vitro diagnostics ordinance mirroring the EU IVDR. The January 2025 amendment mirrors the EU Reg 2024/1860 transition extensions and defers the in-house-test irreplaceability-proof duty to end-2030.

• 2022-05-26: Entry into force
• 2025-01-01: Transition-alignment amendment in force (mirrors Reg (EU) 2024/1860)
• 2030-12-31: In-house IVD irreplaceability-proof duty applies

Regulation (EU) 2016/679

EU data protection regime applying to personal data processing. The Digital Omnibus (data) proposal of November 2025 (COM(2025) 837) would amend it; still under negotiation in Council, not adopted.

• 2018-05-25: Date of application
• 2025-11-19: Digital Omnibus (data) amendment proposed (COM(2025) 837)

• Data Privacy in Clinical Trials: GDPR Meets DSG

SR 235.1

Swiss federal data protection act (revised).

• 2023-09-01: Revised act in force

• Data Privacy in Clinical Trials: GDPR Meets DSG

Regulation (EU) 2025/327

EU framework opening electronic health data for primary use across borders and secondary use for research and innovation, with obligations for EHR-system vendors.

• 2025-03-26: Entry into force
• 2027-03-26: General application; core implementing acts due
• 2029-03-26: First priority categories exchange live; secondary use applies for most categories
• 2031-03-26: Second priority categories; secondary use for remaining categories incl. genomic data

SR 816.1

Swiss electronic patient record act. A total revision into the EGDG (elektronisches Gesundheitsdossier, opt-out model on a single federal platform) is before Parliament; operation is targeted around 2030.

• 2017-04-15: Entry into force
• 2025-11-05: EGDG Botschaft (total revision) adopted by the Bundesrat

Regulation (EU) 2023/2854

EU horizontal rules on access to connected-product data, business-to-business data sharing, and cloud switching.

• 2024-01-11: Entry into force
• 2025-09-12: Main obligations apply
• 2026-09-12: Access-by-design duty for newly marketed connected products (Art. 3(1))
• 2027-09-12: Unfair-terms rules extend to pre-existing long-term contracts

• Cloud Service Contracts: Jurisdictional Complexity

Directive (EU) 2022/2555

EU directive raising cybersecurity obligations for essential and important entities; technical requirements for digital-infrastructure entities specified by Implementing Regulation (EU) 2024/2690. Five Member States were referred to the CJEU in July 2026 over missing transposition.

• 2024-10-17: Member-State transposition deadline

• Cybersecurity Requirements for Connected Medical Devices: NIS2 Implications

SR 128

Swiss information security act, including the 24-hour reporting obligation to BACS for cyberattacks on critical infrastructure. The staged commencement completed in October 2025.

• 2024-01-01: Entry into force (staged)
• 2025-04-01: Critical-infrastructure reporting duty to BACS in force (24h)
• 2025-10-01: Reporting-duty sanctions in force

• Cybersecurity for SaMD: Meeting MDR and Beyond

Regulation (EU) 2024/2847

EU regulation on horizontal cybersecurity requirements for products with digital elements.

• 2024-12-10: Entry into force
• 2026-06-11: Notified-body framework applies (Arts. 35–51)
• 2026-09-11: Reporting obligations (Art. 14) apply
• 2027-12-11: Main obligations apply

• Cybersecurity for SaMD: Meeting MDR and Beyond

Regulation (EU) 2024/1689

EU horizontal regulation on artificial intelligence, applying risk-tiered obligations. The Digital Omnibus on AI (Regulation (EU) 2026/1744, in force since 27 July 2026) defers high-risk obligations: Annex III standalone systems to 2 December 2027 and Annex I product-embedded systems to 2 August 2028. Transparency obligations (Art. 50) applied on schedule on 2 August 2026; generative systems already on the market before that date have until 2 December 2026 to meet the machine-readable marking requirement.

• 2024-08-01: Entry into force
• 2025-02-02: Prohibitions (Art. 5) and AI-literacy duty (Art. 4) apply
• 2025-08-02: GPAI-model obligations, governance and penalties apply
• 2026-08-02: Transparency obligations apply (Art. 50; not deferred)
• 2026-12-02: Marking grace period ends for pre-August-2026 generative systems (Art. 50(2))
• 2027-08-02: Legacy GPAI models must comply (Art. 111(3))
• 2027-12-02: Annex III high-risk obligations apply (deferred by Reg (EU) 2026/1744)
• 2028-08-02: Annex I product-embedded high-risk obligations apply (deferred by Reg (EU) 2026/1744)

• AI-Enabled Medical Devices: The Regulatory Convergence Problem
• EU AI Act and German Pharma R&D: The 2026–2027 Compliance Cliffs

Regulation (EU) 536/2014

EU regulation harmonizing clinical trial authorization and supervision via CTIS; to be amended by the EU Pharma Package.

• 2022-01-31: Date of application
• 2025-01-31: Transition complete: all ongoing trials under the CTR in CTIS

• Cross-Border Clinical Trial Agreements: Swiss-EU Coordination Post-Brexit
• Austria's Accelerated Clinical Trial Pathway: What the 35-Day Timeline Does Not Tell US Biotech
• Clinical Trials with Pregnant Participants Under the EU CTR: The Gap Between Permission and Practice
• Three Jurisdictions, One Evidence Gap: Cross-Border Clinical Trials with Pregnant Participants

SR 810.30

Swiss human research act governing clinical research on persons.

• 2014-01-01: Entry into force
• 2024-11-01: Revised ordinances (KlinV, HRO) in force; transparency provisions from 1 March 2025

• Clinical Trials with Pregnant Participants in Switzerland: When Protection Becomes Exclusion

Council docs ST-6366/26 (Regulation) + ST-6367/26 (Directive)

Most significant overhaul of EU pharmaceutical law in two decades, replacing Directive 2001/83/EC and Regulation (EC) No 726/2004 and repealing and absorbing the Orphan and Paediatric Regulations; the ATMP Regulation and the CTR are amended, not replaced. Council and Parliament reached a provisional agreement in December 2025; Coreper endorsed the compromise text and the Parliament's health committee (SANT) approved it in March 2026. Formal Council adoption and the Parliament plenary vote (indicatively 11 November 2026) are pending, after which the acts are published in the Official Journal, enter into force 20 days later, and their main provisions apply 24 months after entry into force, around 2028 to 2029. No Official Journal act has been published yet.

• 2023-04-26: Commission proposals (COM(2023) 192 Directive + COM(2023) 193 Regulation)
• 2025-12-11: Council–Parliament provisional agreement
• 2026-03-06: Coreper endorsed the compromise text
• 2026-03-18: EP health committee (SANT) approved the agreed text
• 2026-11-11: EP plenary vote (indicative, expected autumn 2026)

• The 90-Day Rule: How the EU Pharma Package Rewrites Global Filing Strategy for US Sponsors
• The New Orphan Math: Product-Based Exclusivity and What It Does to US Rare-Disease Biotech
• Access Conditionality and the New Cost of Selective EU Launch: What Article 56a Means for US Originators
• Bolar at the Border: Expanded Carve-Outs and Earlier Generic and Biosimilar Entry into the EU
• Transferable Exclusivity Vouchers: Will the EU's Antimicrobial Pull Incentive Actually Work for US AMR Developers?
• Environmental Risk Assessment Reaches Across the Pacific: Supply-Chain ERA Obligations for US Manufacturers Using Asian APIs
• Regulatory Sandboxes for Novel Therapies: A New EU Pathway for US Cell, Gene, and AI-Enabled Therapeutics

Directive 2001/83/EC

Current EU code on medicinal products for human use; to be replaced by the EU Pharma Package.

• Pharma R&D Partnerships: Contractual Risk Allocation
• Biotech Clinical Manufacturing: Regulatory Gray Zones
• AI in Drug Discovery: Intellectual Property and Data Ownership Challenges

Regulation (EC) No 726/2004

Current EU centralized authorization procedure and EMA framework; to be replaced by the EU Pharma Package.

• Cell and Gene Therapy Licensing: Navigating the Hospital Exemption

SR 812.21

Swiss federal therapeutic products act governing medicinal products and medical devices. A third revision is under way in two stages: 3a (digitalisation, paediatric medication safety) is in Parliament; 3b (supply security) is in consultation.

• 2025-09-03: Revision 3a Botschaft adopted by the Bundesrat
• 2026-10-16: Revision 3b consultation closes

• Swiss Pharma Pricing Under Pressure: What the Three-Year Review Means for R&D Investment
• Cell and Gene Therapy Licensing: Navigating the Hospital Exemption
• Swiss MedTech Export: Navigating Third-Country Status

COM(2025) 102 (provisional agreement)

Proposed EU regulation to secure the supply of critical medicines: procurement resilience criteria, contingency stocks, and collaborative procurement. Parliament and Council reached a provisional agreement in May 2026; formal adoption and Official Journal publication are expected toward the end of 2026.

• 2025-03-11: Commission proposal
• 2026-05-12: Council–Parliament provisional agreement

SR 531

Swiss economic supply-security act: mandatory stockpiles (Pflichtlager) for essential medicines and reporting of supply disruptions, the functional counterpart to the EU's critical-medicines initiative.

• 2017-06-01: Totally revised LVG in force

EudraLex Volume 4, Chapter 4 (Documentation)

Revised GMP documentation chapter; risk-management and data-governance principles, draft under finalisation. Final texts targeted for delivery to the Commission in Q4 2026.

• 2025-07-07: Draft published for consultation
• 2025-10-07: Consultation closed

EudraLex Volume 4, Annex 11 (Computerised Systems)

Major revision of the computerised-systems annex (expanded from 5 to 19 pages); draft under finalisation after ~2,900 consultation comments. Final texts targeted for delivery to the Commission in Q4 2026.

• 2025-07-07: Draft published for consultation
• 2025-10-07: Consultation closed

• EU AI Act and German Pharma R&D: The 2026–2027 Compliance Cliffs
• Nordic NIS2 Enforcement: A Fragmented Cybersecurity Landscape for Pharma R&D

EudraLex Volume 4, Annex 22 (Artificial Intelligence)

First GMP annex on AI/ML in manufacturing: static, deterministic models for critical GMP applications; the draft excludes generative AI from critical use, an exclusion under review after the June 2026 EMA workshop. Final texts targeted for Q4 2026.

• 2025-07-07: Draft published for consultation
• 2025-10-07: Consultation closed
• 2026-06-30: EMA multistakeholder workshop on generative-AI scope

AMBV (SR 812.212.1); PIC/S GMP Guide

Switzerland applies the PIC/S GMP Guide via the AMBV under the HMG; tracks EU GMP closely but adopts changes on its own timeline.

Directive (EU) 2024/2853

Revised EU product-liability regime covering software, AI systems, and digital products; replaces Directive 85/374/EEC.

• 2024-12-08: Entry into force
• 2026-12-09: Member-State transposition deadline

• Pharma Supply Chain Liability: When Contracts Meet Reality
• AI-Enabled Medical Devices: The Regulatory Convergence Problem

SR 221.112.944

Swiss product liability act; not yet aligned with the revised EU PLD's software/AI scope, and no revision is pending.

• Pharma Supply Chain Liability: When Contracts Meet Reality

Regulation (EC) No 469/2009

EU supplementary protection certificates extending patent-like protection for authorized medicinal products. The 2023 unitary-SPC and recast reform package remains pending in Council.

• Pharma Distribution Agreements: Parallel Import Protection in Switzerland
• Biotech Licensing: Hidden Contractual Pitfalls

Art. 140a ff. PatG (SR 232.14)

Swiss supplementary protection certificate under the Patentgesetz, mirroring the EU SPC mechanism.

• Biotech Licensing: Hidden Contractual Pitfalls

Regulation (EC) No 1394/2007

EU framework for gene-therapy, somatic-cell-therapy, and tissue-engineered products; to be amended (not replaced) by the EU Pharma Package.

• Biotech Clinical Manufacturing: Regulatory Gray Zones
• Cell and Gene Therapy Licensing: Navigating the Hospital Exemption

SR 810.21; SR 812.21

Switzerland regulates ATMPs functionally rather than in one act: cell- and tissue-based products as Transplantatprodukte under the TxG in conjunction with the HMG, gene-therapy products under the HMG; Swissmedic authorizes both.

• 2007-07-01: TxG entry into force
• 2023-09-29: TxG revision adopted by Parliament

• Cell and Gene Therapy Licensing: Navigating the Hospital Exemption

Regulation (EU) 2024/1938

EU framework on the quality and safety of substances of human origin (blood, tissues, cells) used in humans or to manufacture products, replacing the Blood and the Tissues & Cells Directives.

• 2024-08-07: Entry into force
• 2027-08-07: Main obligations apply
• 2028-08-07: Penalties provisions; final transition from the Blood and Tissues & Cells Directives

SR 812.21; SR 810.21

Swiss coverage of substances of human origin is split: labile blood and blood products under the HMG, tissues and cells for transplantation under the TxG; no single SoHO-equivalent act exists.

Regulation (EU) 2021/2282

EU joint clinical assessment of health technologies, applying first to oncology medicines and ATMPs; selected high-risk medical devices are assessed via implementing acts.

• 2025-01-12: Application begins (oncology / ATMPs first)
• 2028-01-13: Joint clinical assessment extends to orphan medicinal products
• 2030-01-13: Joint clinical assessment extends to all medicinal products (Art. 7)

Regulation (EC) No 141/2000

EU incentives and market exclusivity for orphan medicinal products; repealed and absorbed by the EU Pharma Package once it applies.

• The New Orphan Math: Product-Based Exclusivity and What It Does to US Rare-Disease Biotech

Art. 4 Abs. 1 Bst. adecies, Art. 14, Art. 11b HMG (SR 812.21)

Swiss orphan regime since 2019: orphan status granted by Swissmedic, simplified authorization, and 15 years of Unterlagenschutz (data exclusivity) under Art. 11b Abs. 4 HMG, unlike the EU's 10-year market exclusivity.

• 2019-01-01: Revised HMG orphan provisions in force

Regulation (EC) No 1901/2006

EU framework on medicines for paediatric use; repealed and absorbed by the EU Pharma Package once it applies.

Art. 54a ff. HMG; Art. 140n and 140t PatG

Swiss paediatric regime since 2019: paediatric investigation plan duty under Art. 54a ff. HMG, a six-month paediatric extension of the ESZ under Art. 140n PatG, and a standalone paediatric certificate under Art. 140t PatG.

• 2019-01-01: Paediatric provisions of the revised HMG and PatG in force

SR 251

Swiss cartel act. The 2025 partial revision replaces the qualified-dominance test with the SIEC test in merger control; entry into force is expected not before early 2027.

• 2025-12-19: Merger-control revision (SIEC test) passed in the final vote
• 2026-09-17: Implementing-ordinance consultation closes