As of 2 August 2026, Article 50 of the EU AI Act is fully in force. Companies publishing multilingual content, from e-commerce catalogues to financial reports, must now comply with new . On 20 July 2026, the European Commission published its final guidelines on Article 50, together with the Code of Practice on Transparency of AI-Generated […]
Every Informed Consent Form (ICF), the form through which participants in a clinical study are informed and provide their consent, has a dual purpose. On the one hand, it must meet the requirements of Ethics Committees and regulatory authorities, which are accustomed to rigorous medical and legal language. On the other, it must speak to […]
Innovation requires research, investment and time. But innovation also gains value from the ability to protect it, document it and bring it to international markets. This was one of the topics discussed during Legalcommunity Week in Milan, in a panel dedicated to the role of the pharmaceutical industry in innovation and the state of scientific […]
In 2026, Aglatech14 is once again included in the CSA Research Verified 100, the annual ranking of the world’s top 100 translation agencies and language service providers. CSA Research is an independent research firm specialising in the translation, localisation, and language services industry. Each year, it publishes the Global Market Study, which analyses hundreds of […]
When people think about packaging, they almost always picture consumer products: aesthetics, branding and shelf appeal. In the world of medical device packaging, however, the perspective is completely different. The packaging is not an accessory but an integral part of the device itself. It must preserve sterility, withstand transportation, communicate critical information within just a […]
The year 2026 marks a turning point for the medical device sector. As of this year, EUDAMED is fully operational for its first four modules, the European Commission has presented its proposal to revise the MDR and IVDR Regulations, and national databases are evolving towards increasingly integrated governance-oriented architectures. Completing this picture, artificial intelligence has […]
The global clinical research landscape is evolving rapidly, and Europe has no intention of standing still. While the United States and Asian countries continue to attract an increasing share of multinational studies, European institutions have launched a structured and ambitious response: a two-year plan designed to transform Europe into a more efficient, harmonized, and attractive […]
In the medical device industry, labelling is not merely a regulatory requirement, but a fundamental element in ensuring product safety, traceability and proper use. With the entry into force of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), labelling has taken on an even more strategic role, particularly for companies operating across multiple European […]
Artificial intelligence has revolutionized the translation industry in recent years, making previously unimaginable tools accessible. However, with the European AI Act coming into force in August 2024, the regulatory landscape is changing radically. The world’s first comprehensive regulation dedicated to artificial intelligence is not merely a technical matter: it redefines responsibility, transparency, and security for […]
In the context of Regulation (EU) 2017/745 (MDR), the concept of Technical Documentation has undergone a profound transformation with the MDR Product Record. It is no longer a static set of documents to be submitted for CE marking, but a dynamic system that accompanies the device throughout its entire lifecycle. Today, for medical device manufacturers, […]
