Knowledge Center
The Regulyn Knowledge Center provides comprehensive resources on EU regulation and references to trustworthy additional materials.
Explore Regulyn’s articles and curated links to official guidelines and regulation.
Contents
All content on the Knowledge Center is reviewed regularly by experienced legal professionals to ensure accuracy and alignment with regulatory changes.
Last updated on 30 January 2026.
AI Compliance and Governance
Regulyn Resources
EU AI Act Risk Categories Explained - An overview of the EU AI Act Risk Categories, including practical examples.
Regulation and Official Guidelines
Artificial Intelligence Act (EU 2024/1689, “EU AI Act”): Regulation governing AI systems, broad territorial scope.
Guidelines on AI system definition (published by European Commission)
Guidelines on prohibited AI practices (published by European Commission)
Guidelines for providers of GPAIs (published by European Commission)
Additional Resources and Upcoming Changes
Digital Omnibus on AI Regulation: a proposal to simplify AI Act
Research and Development
Regulation and Official Guidelines
Clinical Trials Regulation (EU 546/2014, “CTR”): Regulation governing clinical trials
Medical Devices Regulation (EU 2017/745, “MDR”): Regulation governing development, testing and safety of medical devices
In Vitro Diagnostics Regulation (EU 2017/746, “IVDR”): Regulation governing in-vitro diagnostic medical devices, applicable from 26.5.2022 in updated form
ICH GCP Guidelines for Good Clinical Practice (EMA Approved): an international guideline for good clinical practice. A recently updated version came into effect on 23 July 2025.
Additional Resources and Upcoming Changes
European Health Data Space Regulation (EU 2025/327, “EHDS”): A comprehensive regulation governing health data use within EU. This new regulation is already in force and will start to apply from 26 March 2026.
Regulation on standards of quality and safety for substances of human origin intended for human application (EU 2024/1938, “SoHo Regulation): A comprehensive regulation governing samples of human origin (SoHo) for human application. This new regulation entered into on 7 August 2024, and will apply after a transitional period (7 August 2027).
Act on Secondary Use of Social and Health Data: A Finnish Regulation governing secondary use of data, imposing data permit and security requirements (Note: changes to Secondary Use Act will apply from June 1 2026).
‘Pharma Package’ The Council and the European Parliament have reached an agreement on the ‘pharma package’, a new set of rules that will increase patients' access to medicine and make the EU’s pharmaceutical sector fairer. The legislation will enter into force once published in the official journal and apply after a transitional period.
Agreements
Regulation and Official Guidelines
EU Standard Contractual Clauses: standard contract terms for international personal data transfers from EU/EEA to certain third countries
EU Research and Development (R&D) Block Exemption Regulation (EU 2023/1066, “R&D BER”): Regulation providing a limited exemption for specific R&D agreements from the general ban on agreements limiting competition.
Additional Resources
EU DESCA Consortium Agreement: a widely used consortium agreement model for EU consortiums
Data Protection
Regulyn Resources
Can pseudonymisation make data anonymous? Analysis of a recent EU court ruling
Regulation and Official Guidelines
General Data Protection Regulation (EU 2016/679, “GDPR”): Regulation governing personal data processing in the EU.
European Data Protection Board Guidelines: Official EDPB Guidelines on various aspects of the GDPR and its interpretation
Additional Resources and Upcoming Changes
Digital Omnibus: EU proposal to simplify data protection and data use regulations