01 Mar The geko™ device receives UK Conformity Assessed Mark
The geko™ device has officially been assessed and certified with meeting the requirements of Part II of The Medical Devices Regulations 2002, Annex II (excluding section 4), for:
- to increase blood circulation
- for the prevention of venous thrombosis
- for the prevention and treatment of oedema
- for promoting wound healing
- for the treatment of venous insufficiency and ischemia
- for promoting the healing of tendon and ligament injuries
- for alleviation of the symptoms of urinary and faecal incontinence
Meeting regulatory requirements
This has been recognised with the UK Conformity Assessed (UKCA) Mark which will be placed on all medical devices in the UK.
Following Brexit, the UK has introduced its own regulatory framework to conduct a conformity assessment for new products, including medical devices. The UKCA will replace the CE marking regime that is currently used for certain goods in Great Britain, and the mark is given to medical devices to confirm that health, safety and environmental regulations have been met.
Presenting new possibilities
The UKCA Mark proves that a medical device is fit for its designed purpose, meeting the necessary standards and legislation required. Receiving this certification ensures continuity of supply of the geko™ device into the UK, providing a pathway for innovation while the EU tackles issues with the implementation of its revised regulations for medical devices.
With this regulation in place, we are able to market the geko™ device in the UK, helping patients access life-changing treatments to prevent blood clots, enhance wound healing, and treat and prevent oedema.
A brighter future for the NHS
The adoption of innovation benefits the wider healthcare system as well as directly improving patient outcomes. Medical devices are helping patients become less reliant on nurses and other healthcare professionals to deliver effective treatment, driving them to feel empowered to take charge care of their own conditions. This in turn can contribute to the freeing up of time, money and resources for healthcare systems – which are under mounting pressures in a post-pandemic world. The UKCA Mark is a step in the right direction to building a brighter and healthier future for all.
Find out more about the geko™ device here.