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A medical device is any device that can be used by people alone or in combination (as stated by the maker) for a medical purpose.
This includes any equipment, software, materials, or other items. The term “medical device” refers to a number of items, including breast implants, walking sticks, and contact lenses.
In vitro diagnostic devices are included in the category of medical devices. For example, blood glucose, lateral flow, and pregnancy tests, these medical instruments are used to test samples of tissue, bodily fluids, and blood that have been removed from the body.
Implantable medical devices, like cardiac pacemakers, are also considered medical devices; these devices are typically implanted and may or may not need external sources of power or functioning.
The Europe Medical Devices market accounted for $XX Billion in 2021 and is anticipated to reach $XX Billion by 2026, registering a CAGR of XX% from 2022 to 2027.
Additional 180 oxygen concentrators, 2000 pulse oximeters, and other medical supplies have been given to outpatient facilities in Georgian villages thanks to funds from the European Union (EU).
The supplies were acquired as part of a significant EU-United Nations initiative to support rural healthcare facilities and lessen the effects of the COVID-19 outbreak in the nation.
In order to increase access to healthcare, the programme will eventually equip village ambulatory units with telemedicine technology.
At a symbolic handover ceremony, the concentrators and oximeters were presented to Georgia’s Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health, and Social Affairs by WHO Representative and Head of the WHO Country Office in Georgia, and, EU Ambassador to Georgia.
Updates on MedMira Inc.’s regulatory development in Europe and any markets that have accepted the CE mark are provided. Recently, MedMira received the CE mark for three items, and the regulatory agency is presently considering four further applications from the company.
The IVDR on medications from MedMira, such as the REVEALCOVID-19 and VYRA product lines, is similarly quite low. MedMira’s goods stand out among its rivals in the European market because of thorough testing done on all of their products and compliance with international standards like MDSAP.
As a result, MedMira was able to very easily adapt their in-vitro equipment to conform with IVDR.