MHRA Releases IVD Guidance for Notified Bodies
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance for notified bodies pertaining to the regulation of in vitro diagnostic (IVD) products used in home healthcare settings for self-testing.
Assuring the safe use of these products is a challenge, the agency notes, as there is unlikely to be a healthcare professional present to guide the patient in the proper use of the device or the correct interpretation of its results. "It is therefore vital that self-tests are suitable for lay use," MHRA writes.
To provide a framework for assuring suitability and safety, MHRA on 6 July 2012 released its Guidance for notified bodies on the regulation of IVDs for self-testing-a 13-page document outlining the scope of the guidance, how to assess the devices for lay use, labeling requirements for self-test IVDs, information to be contained within a self-test IVD's instructions for use, and conformity assessment routes for self-test devices.
In a statement, MHRA said the guidance is "intended to support the notified body assessment and although it is not aimed directly at manufacturers of self-tests, notified bodies may wish to share this guidance with prospective clients in order to demonstrate regulatory expectations."
Under the guidance, notified bodies will be required to assess the actual use of the device through lay user studies, which MHRA said is an "expectation." The studies should include an assessment of the ease and correctness of collected samples, the patient's ability to use the device by following the labeling and instructions for use, the patient's ability to read the result of the IVD and subsequent ability to interpret the results. MHRA notes all four elements of the study should be included.
Labels for the devices must be understandable by a non-professional lay-user, including how to interpret results, the concepts of false-positives and false-negatives, what actions to take depending on the results of the test and when to consult medical professionals.