What is EU-MDR? What is a medical device? How are they classified? On what basis the medical devices are classified (diagnostic vs therapeutic)?

Question

Accepted Answer

EU-MDR means European union medical device regulation which has set of laws that sets out rules for production, Manufacturing, Distribution and regulation within EU members states.

Medical device may be an apparatus, Implant, application or a software intended by the manufacturer for use on human beings for diagnosis or treatment.

Based on risk management and regulatory which provides safety and efficacy , classifies to 3 types (CLASS-I,CLASS-II,CLASS-III) i.e., Low risk, medium risk and high risk.

What is EU-MDR? What is a medical device? How are they classified? On what basis the medical devices are classified (diagnostic vs therapeutic)?

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