Open Joint Letter on the AI Act Regulating AI-embedded Medical Devices
On 15 July 2026, CDT Europe and other 5 organisations representing standardisation, consumers, digital rights, doctors, pharmacists and hospitals published an open joint letter calling EU policymakers to maintain medical devices under the scope of the AI Act.
In the letter, we express our serious concerns regarding the European Commission’s proposal to exclude medical devices and in vitro diagnostics from the scope of the AI Act. Ensuring the safety of AI-embedded medical devices is a matter of patient safety, consumer protection and public trust in healthcare. This change, part of the Medical Devices (MDR) and the In Vitro Diagnostic Medical Devices Regulations’(IVDR) revision, is an unacceptable rollback. Given that these laws were not designed to regulate AI, these changes strip AI-embedded medical devices of the core horizontal safeguards mandatory for high-risk AI systems, at the expense of patient safety and consumer protection.
We therefore strongly call on co-legislators to retain these devices within the full scope of the AI Act and to prevent regulatory gaps. Only this way can the EU ensure consumer safety and harmonised, robust oversight of AI-specific risks and harms in healthcare.
Potential Avenues for Redress for AI-related Harms under EU Equality and Non-Discrimination law: A Visual Explanation
In this third instalment of the series, we look at the opportunities afforded by EU equality and non-discrimination law in providing redress for AI-related harms.
As Brussels starts emptying for the summer, the risks of frontier AI models continue to capture the attention of policymakers as a key chapter of the AI Act becomes enforceable, and disclosure rules around the use of AI systems and AI-generated content are further clarified.
CDT Europe’s Feedback on the Draft Guidelines for the Classification of High-Risk AI Systems under the AI Act
CDT Europe responded to the European Commission’s consultation on the draft guidelines for the classification of high-risk artificial intelligence systems.
Open Joint Letter on a Public Reassessment of the EU-US Adequacy Decision
On 29 June, the US Supreme Court ruled that US President Trump can remove the leaders of independent agencies and commissions, overturning nearly 90 years of precedent limiting executive power. This decision raises serious questions about one of the key safeguards underpinning the EU-US Data Privacy Framework adopted in 2023: independent supervision.
