There are many reasons for medical device regulation and for businesses in the pharmaceutical and medical industry, not least to ensure that patients and end users of their products receive the very best quality, value for money and most crucially, that medical devises are safe.


Some medical device regulation applies to devices as simple as surgical gloves or hand operated dentist equipment such as dental mirrors. These items, whilst requiring some degree of medical device regulation don't fall into the heavily regulated category due to the fact that they are not considered to be high risk items.