PCOS: effectiveness of green tea in weight loss

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of the reproductive age. This is a fairly common condition that affects 5-10% of women of childbearing age and can adversely affect metabolism and reproductive capacity. The causes of polycystic ovary syndrome are not yet fully known, but it is believed to be due to…

Anise: benefits and therapeutic properties

Anise: benefits and therapeutic properties Limited and preliminary clinical research has examined the efficacy of anise for diabetes, dysmenorrhea, and menopausal hot flashes. Antioxidant, anti-inflammatory, and antimicrobial properties have also been identified. This narrative review summarizes human and animal studies reporting the potential health benefits of aniseed and highlights areas for future research. More

MDR Regulation: Translation and repackaging activities

With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulation for medical devices and in vitro medical devices has changed dramatically. The main objectives of the 2017/745 European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable…

Legacy devices: Instructions and clarifications

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. The main objectives of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable, and…

The obligations of importers and distributors under MDR

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…

MDR: what are the new obligations and roles of the agent?

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…

MDR: The new roles of economic actors

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,…

Pueraria Lobata: Treatment for Spondylosis and Microbiota

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…

MDR regulations: the technical file

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)…