Safety of medical devices
With over two million medical devices available today, categorized into more than 7000 generic devices groups 1, the need to ensure that they are reliable and safe is a must!
Medical devices range from magnetic resonance imaging (MRI) and artificial heart valves to syringe needles, glasses lenses and AI learning algorithms. Medical devices diagnose, monitor, treat of disease or rehabilitate following disease or injury.
When running clinical investigation on medical devices, safety of the patients is a priority and a requirement for regulations. Care for the patient’s well-being also continues after the product has been registered and is on the market. Regulation is primarily intended to ensure that patients have access to safe, effective, and high quality medical devices, and to avoid access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community.
A medical device in only allowed to put on market in Europe if it meets certain legal requirements. The main regulations include Medical Device Regulations (MDR) and In Vitro Device Regulations
(IVDR). Furthermore, depending on the risks associated with a medical device, an independent notified body has to be involved to check and/or test whether these legal requirements are fulfilled.
If the requirements are being fulfilled, the notified body will issue a certificate. After that the medical device is admitted to trading.
Failure to comply with legal requirements is not only unethical and endangers patient health, but can also can lead to penalties and recalls, damaging your brand reputation and overall business prospects. Moreover, it should be emphasized that the development of the global medical device market is associated with the occurrence of an increasing number of adverse events, including serious and fatal events. That is why after placed a medical device on the market, it is necessary to monitor devices’ performance, detect potential device-related safety issues, and contribute to benefit-risk assessments.