EU MDR Insights

What is EU MDR?

The EU Medical Device Regulation (MDR) is a regulation setting requirements for placing medical devices on the EU market. It aims to ensure the safety and performance of medical devices, improve traceability, and enhance market surveillance. Manufacturers must comply with these regulations to legally sell their devices in the European Union.

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What other technologies are related to EU MDR?

EU MDR Complementary Technologies

ISO 13485

ISO 13485 is a quality management system standard specifically for medical devices. Compliance with this standard can greatly facilitate meeting EU MDR requirements related to quality management.

mentioned alongside EU MDR in 5% (591) of relevant job posts

MDSAP

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to be audited once for compliance with the regulatory requirements of multiple regulatory authorities. While not directly part of EU MDR, participation can streamline compliance efforts.

What is EU MDR?

What other technologies are related to EU MDR?

EU MDR Complementary Technologies

Which job functions mention EU MDR?

Which organizations are mentioning EU MDR?