Regulation of Chemicals Event Report

Published 6th December, 2020

Issues from manufactured chemicals remain ever-present, and from time to time they come back into the public eye. 

Risk management concerns range from safety evaluation and manufacture through to distribution, use and disposal, and vary between single products and products in combination. 

In the first of two sessions, specialists from the MHRA discussed existing approaches and the future in relation to medical products and medical devices.

This emphasised that the intended use and relevant endpoints are as key in determining the classification and regulation of a medical device as for a medicine or a vaccine. 

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.

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