Why medical regulatory is important?

Medical regulatory is the process of ensuring that medical products, such as medicines, medical devices and blood components, meet the standards of safety, quality and efficacy before they are placed on the market. Medical regulatory is important for protecting public health and enabling innovation and research that can benefit patients.

One aspect of medical regulatory is the classification of medical devices according to their level of risk. Medical devices are classified into four classes: Class I, IIa, IIb or III, with Class I being the lowest risk and Class III being the highest risk. The classification determines the type and extent of assessment that a medical device needs to undergo before it can be marketed.

Class IIa medical devices are those that present a low to medium risk to the patient or user. They are usually devices that are intended for short-term use inside the body (between 60 minutes and 30 days), or devices that have a measuring function or a sterile component. Examples of Class IIa medical devices include short-term corrective contact lenses, suture needles, standard hearing aids and TENS devices.

One example of a Class IIa medical device are the devices manufactured by Bodystat, which are devices that measures body composition using bioelectrical impedance analysis (BIA). BIA is a method of estimating body fat percentage, lean mass, total body water and other parameters by sending a small electrical current through the body and measuring its resistance. Bodystat is intended for use by healthcare professionals or individuals under their supervision for monitoring or screening purposes.

Bodystat, like any other Class IIa medical device, needs to comply with the requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), which are based on the EU Medical Devices Directive 93/42/EEC (MDD). This means that Bodystat needs to undergo a conformity assessment by an Approved Body (a UK-based organisation that is authorised to assess medical devices) to verify that it meets the essential requirements for safety and performance. 

By following the medical regulatory process, Bodystat can demonstrate that it is a safe and effective device that can provide useful information for health management. Medical regulatory also helps to ensure that Bodystat  can be traced and monitored in case of any adverse events or recalls. Medical regulatory thus plays a vital role in ensuring the quality and safety of medical devices for patients and users.