How are Covid-19 Testing Kits regulated?

How have COVID-19 testing Kits been regulated? 

COVID-19 testing kits are considered to be medical devices. This means for a medical device to be safe to use, it must have a valid CE mark, this is a mandatory. The CE mark is a declaration by the company that the test meets the required legal criteria in said country. 

These regulatory requirements aim to ensure that the products do not compromise the safety of patients and users, and are designed and manufactured to achieve the performance specified by the manufacturer for it’s stated purpose.

Both the sample collection kit and the COVID-19 test (that tests the sample) MUST carry a CE mark.

CE marks are not issued by the MHRA. They are placed on the product by the manufacturer following registration with a competent authority such as the MHRA.

Please note not all Antigen Rapid Testing kits have been registered with the MHRA, we offer the  ActivXpress* Antigen Rapid Testing kit, which has been registered with the correct competent authority. 

The MHRA is the designated competent authority that administers and enforces the law on medical devices in the UK and has a range of investigatory and enforcement powers to ensure the safety and quality of medical devices in the UK.

These regulatory requirements aim to ensure that the products do not compromise the safety of patients and users, and are designed and manufactured to achieve the performance specified by the manufacturer for the stated purpose.

 

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