Most life science companies tracking the EU AI Act amendments have been focused on the high-risk AI documentation requirements, the technical files, instructions for use, and database registrations. In April, those deadlines were pushed back to 2027 and 2028. What did...
The European Commission proposed the EU Biotech Act on December 16, 2025. Final adoption is expected in late 2026 or 2027. Until then, the December 2025 proposal text is the working document every life science company should be reading. The Act does not change one...
Most medical device manufacturers invest heavily in translation during the pre-market phase, localising IFUs, labels, and packaging across EU member states ahead of CE marking. That effort is visible, deadline-driven, and budgeted. What comes after is far less visible...
Europe accounts for around 26.4% of the global medical device market. For manufacturers entering the EU, label compliance is one of the practical requirements to get right, and one that is frequently misread. Many manufacturers approach the physical medical device...
The European Commission wants to simplify medical device regulations. Everyone is talking about reduced burden, but will you actually translate less? The short answer: probably not. In fact, you may end up translating more. While the proposal introduces potential...
The EU just set a hard deadline for EUDAMED. Starting May 28, 2026, manufacturers must use EUDAMED for registration across four modules. Translation becomes a critical requirement for market access. Manufacturers must provide device information, instructions for use,...
For pharmaceutical companies entering the Swiss market, complying with Switzerland’s regulatory framework is essential to ensure patient safety, product quality, and market access. Swissmedic, as the national authority that governs all medicinal products through the...
For medical device and In Vitro Diagnostics manufacturers entering the Swiss market, complying with Switzerland’s regulatory framework is essential for patient safety, quality, and market access. After Switzerland’s separation from the EU system, Swissmedic introduced...
The UK’s clinical trial framework is governed by the Medicines and Healthcare products Regulatory Agency (MHRA), which ensures that studies are conducted safely, ethically, and transparently. A key aspect of this framework is its focus on clear and accurate language...