A Medical Device Based on Sodium Hyaluronate to Create the Ideal Environment for Natural Conception I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. The Key Role of Sperm Motility in Conception Sperm motility is…
Navigating the Future of Medical Devices: A Deep Dive into the European Commission’s MDR Revision and Industry Proposals for a More Efficient and Innovative Landscape The European Commission has officially announced the launch of the Medical Device Regulation (MDR) revision, a welcome development for the industry. This initiative, communicated by European Commissioner for Health, Olivér…
MDR Transition Extended Beyond 2024: Ongoing Market Access for Our Nasal Kits The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices across Europe. Thanks to the extended transition timelines, devices compliant with the MDD Directive can remain on the market until December 31, 2027, for…
Ensured Continuity: Our Osteoarticular Line Is Ready for the MDR Future The Medical Device Regulation (MDR), in force since May 2017 and fully applicable as of May 2021, governs medical devices in Europe. Thanks to deadline extensions, devices compliant with the previous MDD Directive may continue to be marketed until December 31, 2027 for Class…
Since 2024, our lipogel medical device for atopic skin has been MDD certified The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices in Europe. Thanks to the extension of deadlines, devices compliant with the MDD Directive may continue to be marketed until December 31, 2027…
Topical gel and anal solution for the treatment of anorectal disorders The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices in Europe. Thanks to deadline extensions, devices compliant with the MDD Directive can continue to be marketed until December 31, 2027, for Class III and…
Study on the Effectiveness of Simethicone in Water for the Treatment of Gastrointestinal Disorders in Newborns Gastrointestinal disorders in newborns, such as bloating and infant colic, are common conditions that can cause significant discomfort for both infants and their parents. These disorders are often a source of concern as they can affect the newborn’s well-being…
MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028 The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation. However, because of concerns…
From a scientific perspective, Clinical Trials refer to the systematic study method conducted on humans (patients or healthy volunteers) with the purpose of verifying the effects of a product and/or identifying any adverse reactions, studying its absorption, distribution, metabolism, and excretion to establish its efficacy and tolerability. Clinical Trials must therefore confirm or refute the…
Requirements for Clinical Trials: the Ministerial Decree of March 20, 2023 by the Ministry of Health The Decree of March 20, 2023, concerning the requirements for facilities conducting clinical trials, is a significant regulation for the healthcare sector. It was published in the Official Gazette on June 14, 2023, and issued by the Ministry of…