What are Regulations?
Products must meet certain requirements to be sold on the market. This is particularly important for items that are sold for medical purposes.
See below for an explanation of the regulations and standards that the products we offer comply with.
What does ‘UKAS accredited’ mean?
UKAS stands for United Kingdom Accreditation Service. ‘Accreditation’ means an organisation can carry out certain processes reliably and effectively, with a high degree of accuracy. UKAS is the national accreditation for the UK. The government use UKAS to assess organisations that offer services such as testing, inspection and certification.
A company must go through a lengthy process to become UKAS accredited. This includes reviews into management and the way procedures are carried out. The competence of a company must also be tested. Therefore, if a company is UKAS accredited, this shows they have met the highest standards.
What does ISO 13485:2016 accredited mean?
ISO 13485 regulations are for medical devices and services. ISO stands for International Organisation for Standardisation. This means that a product which meets ISO standards is compliant with requirements which are agreed across the world. Medical devices include products, equipment or in vitro devices that are used for diagnosis, and the prevention of illnesses or diseases.
By having ISO 13485:2016 accreditation, a company has been able to assure the safety and quality of products for medical use.
What does CE certified mean?
CE marking applies to products that are sold in the European Economic Area. CE certification confirms that the manufacturer of a product or device has checked that it meets EU health, safety and environmental standards. Furthermore, CE certification allows the free movement of goods in the EU market and shows that a product complies with EU legislation.
Importantly, the CE mark certifies that the product has been assessed before being sold on the market.
What does ‘Emergency Use Authorisation by the FDA’ mean?
If a product is authorised for Emergency Use by the FDA, this means that it is allowed to be used in an emergency for diagnosis, or to treat and prevent illness, even if the product has not been approved. This tends to be the case when there are no approved alternatives that can be used.
The Food and Drug Administration takes the responsibility of ensuring that products, drugs and medical devices are safe and protect people’s health in the US.