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The Regulation on Medical Devices (MDR) and the Regulation on in-vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017. These regulations effectively replaced decades-old legislation and created new transparency and quality requirements for medical device companies in the European Union. Although in effect today, these regulations will be phased in over the next five years.

New quality and risk management requirements include more specific guidelines for the production and quality procedures associated with devices. The MDR requires companies to create a documented risk management plan for medical devices taht identifies possible risks and thoroughly evaluates the information gained from a device's production phase to identify potential hazards.

The MDR also brings some changes to the classification of medical devices. Medical devices are currently classified as either Class I, Class IIa, Class IIb, or Class III. The higher the risk, the higher the classification. Spinal cord contact by the device now qualifies as a Class III. Certian medical apps for smartphones are now classified according to their unique use.

The Eudamed Database is an attempt to make medical device safety information more accessible, to both the medical profession as well as the public. This database is to include information on devices' market surveillance, safety and clinical performance and clinical investigation information.

The ultimate goal of these new regulations is to improve quality, safety and transparency for medical devices throughout the EU. All medical device manufacturers and distributors will have to abide by the new regulations. As a result of these changes, medical device manufacturers need to make sure they are in compliance with the new classification rules. Let Product Safety Consulting help navigate the complex Safety Certification process for your company.