Biocompatibility (the response in humans) is usually evaluated for devices by means of a risk assessment process, based on toxicological data and expert judgement and in keeping with ISO standards.
Testing in animals is now only justified if that is not possible.
In times of unprecedented public health need (for example tests for Covid-19 coronavirus) manufacture can therefore go ahead based upon this process as long as the input parameters are tightly controlled.
The need to expedite vaccine manufacture and clinical trials as well as to repurpose medicines for Covid-19 also led to very wide collaboration between MHRA, pharmaceutical companies and academia, leveraging pre-existing knowledge and pathways and using a rolling process of data review.
The success of these approaches has meant that they and other initiatives will be fed back into how the MHRA operates, especially important as from next year it will be the UK’s standalone regulator of medical products.