Medical devices (MD) are widely used by medical professionals, and are essential tools for diagnostics, life support, and compensating for disabilities. Many different types exist. Some are implantable, such as prostheses and pacemakers, while others are not, such as hearing aids and glasses. Some medical devices can be custom made. This is true for dental implants. Today, the term medical device also applies to software that helps patients calculate the right dose of medication to inject, or monitors heart failure.
Under the responsibility of manufacturers, medical devices must be classified according to the risk level associated with their use. These include Class I medical devices, with the lowest risk level, Class IIa with a moderate risk, Class IIb, with an elevated risk and, finally, Class III, the highest risk level. The medical device regulations were adopted in 2017 to reinforce and harmonise all rules at the European level. They have been in force since 26 May 2021.
The regulation of medical devices is extremely strict. In Europe, it takes the form of the CE mark, a certification guaranteeing full compliance of the MD with regulatory requirements, particularly in terms of safety and clinical benefits. The new European Medical Devices Regulation 2017/745, which came into force in May 2021, was a major development. First, it increases patient safety through clinical assessment of MD and by enhancing surveillance of the devices once they are on the market. It also provides for the introduction of a unique MD identification system for better traceability in the event of non-compliance. Finally, it increases transparency of information by establishing a EUDAMED, a publicly available European database. It integrates several electronic systems to consolidate and process information from medical devices and their manufacturers into six separate modules: actors’ registration, unique device identification and registration (UDI), notified bodies and certificates, clinical investigations and performance studies, and vigilance and market surveillance.
However, the task of implementing the new regulation is quite complex for manufacturers. In addition, manufacturers can access the European Medical Device Nomenclature (EMDN) to guide them in registering their MD in EUDAMED. Click here to visit our page designed to facilitate your research on MD regulations. Please contact us if you would like to take your research a step further by requesting an expert assessment.