With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR (Medical Device Regulation), the figures of economic operators were, at last, regulated; figures that were not fully considered in the…
Economic players, new definitions, and the roles players can play in the medical device market With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR regulation, the figures of traders were,…
Targeted preparation of Pueraria lobata improves clinical symptoms of cervical spondylosis by regulating the intestinal microbiota balance Cervical spondylosis refers to degenerative changes in the cervical intervertebral disc and its accessory structures, along with corresponding symptoms caused by the secondary degeneration of intervertebral joints stimulating or compressing the spinal cord, nerves, and blood vessels. The…
When is a change in a medical technical file considered significant under Art. 120(3)MDR? A Medical Device Manufacturer with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) may place its devices on the market even after May 26, 2021 (date of full implementation of MDR (EU) 2017/745)…
Red Yeast Rice: Safety Under Review, Data in Hand Red yeast rice has long entered the daily routine of those seeking nutritional support for cholesterol control. In Europe as in Asia, supplements containing it are among the most widely used, often perceived as a “natural” solution and therefore, by definition, harmless. But is it really…
Red yeast rice, LDL cholesterol, dietary supplements, statins, European regulation For years, monacolin K has symbolized the meeting point between nutraceuticals and cholesterol management. Authorized with an official claim by EFSA, it has become firmly established in the dietary supplement market aimed at maintaining normal LDL cholesterol levels. Today, however, the scenario has changed. The…
Probiotici nell’esofago di Barrett: Potenziali benefici nella prevenzione e trattamento dell’adenocarcinoma esofageo If underestimated, gastroesophageal reflux can induce Barrett’s esophagus, a complex precancerous condition characterized by metaplasia at the gastroesophageal junction, where the normal squamous epithelium is altered (columnar epithelium) and can lead to the development of esophageal adenocarcinoma. The molecular pathogenesis of the disease…
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