Regulatory Tracker

Regulation (EU) 2017/745

EU framework governing the placing on the market and conformity of medical devices.

• 2021-05-26: Date of application
• 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

SR 812.213

Swiss medical devices ordinance, aligned with but distinct from the EU MDR.

• 2021-05-26: Entry into force (revised)

• 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.

• 2022-05-26: Date of application
• 2025-05-26: QMS-in-place condition for extended transition
• 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

Regulation (EU) 2016/679

EU data protection regime applying to personal data processing.

• 2018-05-25: Date of application

• 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

Directive (EU) 2022/2555

EU directive raising cybersecurity obligations for essential and important entities.

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

• Cybersecurity Requirements for Connected Medical Devices: NIS2 Implications

SR 128

Swiss information security act, including reporting obligations to BACS for critical infrastructure.

• 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 apply

• 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
• 2026-09-11: 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. A 'Digital Omnibus' simplification (provisional agreement 7 May 2026; not yet adopted) would defer high-risk obligations: Annex III standalone systems to 2 December 2027 and Annex I product-embedded systems to 2 August 2028. The 2 August 2026 date remains legally operative until any deferral is adopted.

• 2024-08-01: Entry into force
• 2026-08-02: Annex III high-risk obligations apply (operative; Omnibus deferral pending)
• 2027-08-02: Annex I product-embedded high-risk obligations apply (operative; Omnibus deferral pending)
• 2027-12-02: Annex III high-risk obligations deferred (Digital Omnibus; agreed, pending adoption)
• 2028-08-02: Annex I product-embedded high-risk obligations deferred (Digital Omnibus; agreed, pending adoption)

• 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.

• 2022-01-31: Date of application

• Cross-Border Clinical Trial Agreements: Swiss-EU Coordination Post-Brexit

SR 810.30

Swiss human research act governing clinical research on persons.

• 2014-01-01: Entry into force

• 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. Provisional agreement reached December 2025; formal adoption expected H2 2026; EP plenary vote not yet scheduled (expected autumn 2026), Council adoption to follow, not yet adopted as of 2026-05-30; full application of the operative provisions expected around 2028.

• 2025-12-11: Council–Parliament provisional agreement
• 2026-03-06: Final compromise texts published by Council
• 2026-11-11: EP plenary vote, indicative (OEIL forecast), not yet scheduled

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.

• 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

EudraLex Volume 4, Chapter 4 (Documentation)

Revised GMP documentation chapter; risk-management and data-governance principles, draft under finalisation.

• 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.

• 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-ever GMP annex on AI/ML in manufacturing: model selection, training-data quality, validation, and continuous oversight. New draft.

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

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.

• 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.

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

PatG Art. 140a ff. (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.

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

Regulation (EU) 2021/2282

EU joint clinical assessment of health technologies, applying first to oncology medicines and ATMPs.

• 2025-01-12: Application begins (oncology / ATMPs first)

Regulation (EC) No 141/2000

EU incentives and market exclusivity for orphan medicinal products; under revision by the EU Pharma Package.

Regulation (EC) No 1901/2006

EU framework on medicines for paediatric use; under revision by the EU Pharma Package.