Dr Andrew Kemp JP PhD, reader in biology, head of Scientific Advisory Group BICSc, asks if current medical device and biocides regulatory frameworks are fit for purpose, or are they impeding progress?
The primary purpose of any regulatory framework, must surely be to ensure that products placed on sale in any market are fit for purpose, and safe in their intended use.
The problem is, how do you do this effectively? How do regulators ensure that new products and new technologies can become available to the markets, without letting dangerous/harmful products through the net?
This article is written with a focus on medical devices and chemicals that are defined as biocides, that are intended for use in the medical industry. This is a very complex subject, and this article is intended to demonstrate how complex, and how difficult it is for companies and the regulatory bodies to achieve a balance between too much - and too little - regulation.
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