The Medicines and Healthcare Products Regulatory Agency (MHRA) and Public Health England (PHE) have released a clarification on the nature of diagnostic kits for the current coronavirus.
In a document shared by email, the two bodies say such kits would fall under the present in vitro diagnostic (IVD) Directive, whether for professional use or self-test. PHE provides guidance on the relevant legislation here.
The document also describes the situation for manufacturers seeking to fast-track their products:
“However, under the current climate we understand you may be looking for fast-track approval of your IVD test for COVID-19.
“In this exceptional situation, before any test for COIVD-19 is put into use in the UK it should undergo a review by Public Health England (PHE). You can start this process by submitting your proposal to PHE at email@example.com. We are working with PHE on this.
“If PHE considers that your test is suitable for use in the UK and your test is not already CE marked, you can apply for approval to supply a device that does not comply with the regulations. Send your application to firstname.lastname@example.org and include the following information:
- details of the product(s) (including model name and descriptor)
- reasons why the product does not have a valid CE mark
- clinical justification for requesting a derogation for the product
- explanation of any alternative products on the market and reasons why using these products would not be appropriate
- numbers of product likely to be supplied under the derogation plus an indication of how widely used the product is expected time to gain/re-gain CE certification
“We might ask you for more information once we’ve received your application.
“Be aware that you would be expected to have evidence that the device performs as intended i.e. confirmation that PHE consider the test suitable.”
Read the full document here.