The UK Medicines and Healthcare products Regulatory Agency has published new guidance for Notified Bodies on the regulation of IVD products for home use. It can be downloaded free of charge from the MHRA website.
Home testing is a growing area of healthcare that places new opportunities and responsibilities on those requiring healthcare, notes the MHRA in a press release announcing the guidance. "Users of in vitro diagnostics (IVD) for self-testing (self tests) will not have the benefit of a healthcare professional on hand to advise them how to perform the test or to analyse and interpret the results. It is therefore vital that self tests are suitable for lay use," adds the agency.
In the European Union and other countries that recognize the CE mark, the manufacturer of a self-test not covered in Annex II of the IVD Directive, in addition to complying with the requirements for general IVDs, must lodge an application with a Notified Body for the examination of the design of the device (section 6 of Annex III). This will include aspects affecting its suitability for nonprofessional users.
The guidance document addresses lay studies for self-test devices, requirements for labelling and instructions for use, and conformity assessment routes.
Although the guidance is intended to support the Notified Body assessment and is not aimed directly at manufacturers of self tests, the MHRA notes that Notified Bodies may wish to share this guidance with prospective clients in order to demonstrate regulatory expectations.