by Dr. Sofia Petrescu | May 18, 2026 | Medical
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...
by Dr. Sofia Petrescu | Apr 1, 2026 | Medical
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...
by Dr. Sofia Petrescu | Mar 23, 2026 | Medical
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...
by Dr. Sofia Petrescu | Feb 12, 2026 | Medical
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...
by Dr. Sofia Petrescu | Feb 2, 2026 | Medical
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,...
