When examining the regulations and directives governing the manufacture and sale of disinfectants and cleaners, Clare Clark - BSc (Hons)Microbiology, ACIST, MRB, technical support manager, schülke UK, explains why it is necessary to consider what constitutes a medical device (MD), and why this is significant.
Regulations and directives surrounding the production and sale of disinfectants into the healthcare sector are complex. These regulations are of significance to NHS Trusts and some understanding is required to ensure that chosen cleaning and disinfection products meet legal requirements for use in the hospital environment. Also, as various EU directives come into force, a number of products which have not undergone the necessary processes and approvals will cease to be available.
This has already been experienced in the Republic of Ireland where a leading brand of alcohol based wipes has been discontinued as a direct result of not being supported through the essential directives. Whatever the outcome of Brexit, it is highly likely that the UK will continue to work with EU directives and regulations when it comes to classifying disinfectants and cleaners.
This article gives an outline of the key influencing regulations, what they mean in practice and an indication of the timescale over which they are being implemented.
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