GFI Extends MDD Certificate for GERD Devices

Extension of MDD Certificate for Our Medical Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) Based on Alginates

The MDR regulation, effective from May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Devices Directive (MDD) until December 31, 2027, for Class III and Class IIb implantable devices, and until December 31, 2028, for other Class IIb, IIa, and I devices. Manufacturers should possess a declaration and a “confirmation letter” from the notified body to ensure market continuity during the transition.

We have obtained extensions of the MDR transition period beyond May 26, 2024, for our legacy Class I, IIa, and III devices, confirming MDR compliance through certification application to the notified body. We have also entered into a contract with the notified body and are committed to maintaining compliance with Directive 93/42/EEC and conducting regular surveillance for each legacy device.

We have obtained an extension of the MDD certificate for our Class IIa medical devices for the treatment of GERD. These devices are available in eight different formulations, including six gels and two oral liquid emulsions. The formulations combine active ingredients such as sodium and magnesium alginate, simethicone, myrrh extract, hyaluronic acid, and sodium bicarbonate. The devices come in two pharmaceutical forms: bottles and stick packs, and they treat symptoms of various conditions related to gastroesophageal reflux disease (GERD) in adults, children, and infants.

Each product is formulated to offer targeted action, tailored to the specific stages of the disease and the needs of different types of patients. Our medical devices are effective in treating:

– Gastroesophageal Reflux Disease (GERD)

– Esophagitis

– Heartburn

– Reflux Cough

– Abdominal Pain

– Infant Regurgitation

The bottles and stick packs are designed to provide fast and long-lasting relief, helping to improve the quality of life for patients suffering from these disorders.

The formulations are designed to create an effective protective barrier against irritation and inflammation caused by gastric acid. This defense mechanism helps ensure safe and reliable treatment for GERD patients.

The simethicone present acts specifically against the formation and accumulation of gas, thus relieving symptoms associated with reflux.

Hyaluronic acid is known to actively promote the repair process of damaged epithelium, aiding in the healing of mucous membranes exposed to acid.

Myrrh extract, with its soothing properties, offers immediate relief to inflamed laryngeal mucous membranes, improving comfort during treatment.

Finally, sodium alginate plays a crucial role in mechanically blocking gastroesophageal reflux, protecting delicate mucous membranes from irritation, and promoting long-lasting gastrointestinal well-being.

We are committed to ensuring that our medical devices continue to be available on the market.

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