Manufacturers of medical devices need to take heed of medical device regulation. Medical devices can include such items as breast implants, surgical knives and electrically powered wheelchairs. Other items such as prosthetic limbs also fall under the watchful eye of medical device regulation.
There are many reasons for medical device regulation. Naturally, those reasons that stand-out are often the most essential. Such important reasons are those that affect public health for example when medical devices are not regulated properly. Public health can be affected directly by the medical device itself causing physical harm to a patient when medical device regulation fails. Low quality medical device regulation can also lead to indirect effects on public health. For example, a medical professional such as a nurse or consultant could use medical device equipment that, without their knowledge, could be unsafe for the patient. As well as the distress, pain and emotional turmoil that a badly regulated medical device can bring, it could leave the legal standing of the medical device industry in tatters. This could mean job losses from an otherwise competitive and highly skilled employment sector.
Other reasons for maintaining a compliant medical device regulation strategy is to ensure that the best information about a product is shared and known amongst professionals in the field. Across the world, medical professional work in a variety of conditions including war-zones and in countries where civil unrest is prevalent. In these cases, medical workers may need to make fast decisions on what medical devices to use and when to use them – without hesitation. Product descriptions can be made clear and understandable with the application of medical device regulation.
Medical device regulation also ensures that correctly trained people use medical devices as well. Medical devices can often be let down by the people using the products.. Non-legal use of medical devices can be prevented therefore when businesses take the necessary medical device regulation procedures.
Medical device regulation is necessary worldwide and is the responsibility of different regulatory bodies from country to country. The UK regulator for medical devices is the Medicines and Healthcare Products Regulatory Agency (MHRA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory body in the UK.