EU MDR
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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.
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.
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.
ISO 14971
ISO 14971 is the standard for applying risk management to medical devices. Risk management is a core requirement of the EU MDR.
Number of organizations that mention technology
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Which job functions commonly mention EU MDR?
Public Policy
0.1% of all Public Policy jobs mention EU MDR
View 153
jobs on Sumble
Quality Engineer
0.1% of all Quality Engineer jobs mention EU MDR
View 148
jobs on Sumble
Quality Assurance
212 Quality Assurance jobs mention EU MDR
View 212
jobs on Sumble
Compliance
49 Compliance jobs mention EU MDR
View 49
jobs on Sumble
Operations
233 Operations jobs mention EU MDR
View 233
jobs on Sumble
Which organizations are mentioning EU MDR?
Fisher & Paykel Healthcare
Health Care and Social Assistance
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