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. The 'Digital Omnibus' simplification (COM(2025) 836) was adopted by the European Parliament on 16 June 2026 and given final Council approval on 29 June 2026; it awaits Official Journal publication and enters into force on the third day thereafter. It defers high-risk obligations: Annex III standalone systems to 2 December 2027 and Annex I product-embedded systems to 2 August 2028, while the 2 August 2026 transparency obligations (Art. 50) are not deferred.

• 2024-08-01: Entry into force
• 2026-08-02: Transparency obligations apply (Art. 50; not deferred)
• 2027-08-02: Annex I product-embedded high-risk date (superseded once Omnibus enters into force)
• 2027-12-02: Annex III high-risk obligations deferred (Digital Omnibus; adopted, awaiting OJ publication)
• 2028-08-02: Annex I product-embedded high-risk obligations deferred (Digital Omnibus; adopted, awaiting OJ publication)

• 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. Council and Parliament reached a provisional agreement in December 2025; Coreper endorsed the compromise text in March 2026 and the Parliament's health committee (SANT) approved it the same month. The Regulation and Directive still await the European Parliament plenary vote (indicatively autumn 2026) and formal Council adoption (expected after summer 2026), after which they are published in the Official Journal and enter into force, with the operative provisions applying on a phased basis to around 2028. No Official Journal act has been published yet.

• 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)

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.