What is Medical Device Regulation (MDR)?

Medical Device Regulation Definition

The medical device regulation (MDR) or European Union medical device regulation (EU MDR) is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe. Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The MDR replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive. Under the new medical device regulation, manufacturers need to provide more in-depth clinical data to demonstrate their safety and performance claims.

What is a Medical Device Regulation


Why is medical device regulation important?

It provides patients and care givers with assurance that the device they are using is indeed safe and effective. And the ultimate purpose of medical device development is to aid patients. You risk injuring patients if your equipment isn’t safe.

*Source: https://www.perforce.com

Why does FDA regulate medical devices?

The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure their safety and effectiveness.

*Source: https://www.fda.gov

What is the role of regulatory affairs in the medical device industry?

After a device has been cleared or approved, medical device businesses rely on their regulatory affairs staff. The regulatory function is involved in device surveillance in the post-market setting, ensuring that any adverse events or malfunctions are appropriately reported to the FDA.

*Source: https://www.northeastern.edu

When did FDA start regulating medical devices?

FDA was given the authority to begin regulating all medical devices on May 28, 1976. This is when the President signed the Medical Device Amendments Act.

*Source: https://www.fda.gov

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.