Discover how the AI Act and MedTech Europe impact life sciences.
Yellow Hub’s DIY Portal ensures secure regulatory translations, ISO 13485 and MDR/IVDR compliance.
Introduction to the AI Act
The EU AI Act, which entered into force in 2024, is the world’s first comprehensive regulation on artificial intelligence.
It classifies as high-risk several AI systems, including those used for regulatory translations, clinical documentation, and multilingual content in the pharmaceutical and medical sectors.
The Act’s purpose is to guarantee transparency, safety, traceability and sensitive data protection, with a human-centric AI approach. Its principles align with the Rome Call for AI Ethics, which advocates for the responsible and ethical use of AI.
MedTech Europe: one year after the AI Act
In its press release of 1 August 2025, marking the first anniversary of the AI Act, MedTech Europe highlighted the risk of regulatory overlaps between the AI Act and existing regulations MDR/IVDR for medical devices.
Such overlaps could cause delays in submissions, increase bureaucratic burdens and limit patient access to new health technologies.
Key requests:
- Excluding clinical investigations and performance studies already covered by MDR/IVDR from AI Act obligations;
- Postponing the application of the AI Act to 2 August 2029 for medical AI systems;
- Recognising MDR/IVDR Notified Bodies for AI conformity assessments;
- Introducing AI-specific technology codes to simplify compliance.
The key message: the EU can lead global healthcare AI innovation, but only with a regulatory framework that is clear, coherent and predictable.
Yellow Hub’s DIY Portal: secure data protection and regulatory translations
The DIY Portal by Yellow Hub is a concrete response to the need for sensitive data protection and multilingual regulatory compliance in the life science sector.
Key strengths:
- Data security: content isolation, encryption, pseudonymisation and no storage in public AI engines.
- Human oversight: professional reviewers ensure linguistic accuracy and regulatory compliance.
- Ethics by design: the portal applies responsible AI principles, aligned with European recommendations.
Translations as a compliance requirement
Medical translations are not just about data security — they are a regulatory requirement under MDR/IVDR.
- Required translations include: Instructions for Use (IFU), labels, technical manuals, and post-market documentation.
- Errors in these processes may lead to:
- submission rejections by authorities,
- product recalls
- legal liabilities for manufacturers.
The DIY Portal helps companies comply with the language requirements of MDR, as updated by the European Commission (Rev.3, August 2025).
ISO 13485: a guarantee of quality
The DIY Portal is ISO 13485 certified, the international standard for quality management in medical devices. This reinforces its credibility not only as a secure technological platform but also as a certified tool for regulatory document management.
Clinical studies and linguistic validation
In Clinical Outcome Assessments (COA, PRO, eCOA), translation alone is not enough: a linguistic validation process, including back-translation, is required.
A real-world case: our project with Boehringer, where linguistic validation was essential to ensure accuracy and regulatory compliance.
This highlights a critical point: the use of unchecked machine translation in regulatory contexts is a serious risk. With our portal, all content undergoes human validation, ensuring quality, compliance and patient safety.
| Aspect | AI Act | MedTech Europe | DIY Portal (Yellow Hub) |
| Data protection | Mandatory for high-risk AI systems | Requests clarity to avoid double regulation | Advanced security: encryption, pseudonymisation, human oversight, no public AI storage |
| Innovation & access | Risk of slowdown if overly rigid | Warns against compliance-related delays | Enables safe innovation with compliance and human validation |
| MDR/IVDR compliance | Broad horizontal regulation | Calls for alignment with medical device law | Supports MDR/IVDR translations, ISO 13485 certified, linguistic validation processes |
| Human-centric & ethics | Core principle | Emphasises practical realism | Ethics by design + Rome Call for AI Ethics |
| Application area | All AI systems | Focus on healthcare | Life science multilingual needs: IFU, labels, COAs, clinical documentation |
Conclusion
The AI Act establishes the European framework for safe, transparent AI. MedTech Europe warns of risks from overlapping regulations.
In this scenario, the DIY Portal by Yellow Hub emerges as a best practice:
- protecting sensitive multilingual data,
- ensuring MDR/IVDR compliance,
- operating under ISO 13485 certification
- integrating linguistic validation for clinical studies,
- and combining technology with ethics through human oversight.
A solution that transforms regulatory complexity into a competitive advantage for life science and medical device companies.
