The Medical Device Regulation (MDR) categorizes medical devices into four classes based on their intended purpose and associated risks:

Class I:

• Low-risk devices
• Typically non-invasive
• Examples: bandages, crutches, thermometers, some hearing aids

Class IIa:

• Medium-risk devices
• Examples: catheters, hearing aids, short-term contact lenses

Class IIb:

• Medium-high-risk devices
• Examples: implantable dental devices, blood bags, intensive care monitoring equipment

Class III:

• High-risk devices
• Examples: implantable pacemakers, artificial heart valves, software as a medical device (SaMD)

The classification process involves a detailed risk assessment, considering factors such as the device's intended use, potential risks, and the severity of potential harm. Manufacturers must comply with specific regulatory requirements based on the device's classification.

It's important to note that the MDR has significantly tightened the regulatory framework for medical devices compared to its predecessor, the Medical Device Directive (MDD). This increased scrutiny aims to ensure the safety and performance of medical devices on the EU market.