Looking to simplify the market launch of medical devices, food supplements, and cosmetics? With Gruppo FarmaImpresa, it’s possible Having an innovative idea or a high-quality product is not enough for medical devices, food supplements, or cosmetics. To successfully reach the market, companies must navigate a complex and highly regulated path. In Europe, this process revolves…
EU Court Ruling: Mandatory Labeling in the Language of the Destination Country for Online Cosmetic Sales The Court of Justice of the European Union (Third Chamber) issued a significant ruling on September 19, 2024, in case C-88/23, clarifying the rules for online sales of cosmetics between EU countries. According to the ruling, a company selling…
Latest Regulatory Updates on Medical Devices: What You Need to Know to Stay Compliant The medical devices sector is constantly evolving, driven by both technological advancements and the regulatory complexity governing the market. Adding to the complexity is the fact that medical devices are sometimes subject to intersecting regulations, such as Regulation (EU) 2017/745 (MDR),…
A New Standard for Transparency and Traceability in Medical Devices Regulation (EU) 2024/1860 has introduced significant changes to MDR (EU) 2017/745 and IVDR (EU) 2017/746, facilitating the gradual implementation of Eudamed, the European database on medical devices. This system marks a crucial step towards greater transparency, traceability, and safety in the healthcare sector. Since July…
Extension of the MDD Certificate for Our Medical Devices Supporting Women’s Wellness at Every Stage of Life The MDR Regulation, in effect since May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Device Directive (MDD) until December 31, 2027, for class…