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MDD/MDR

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What is MDD/MDR?

MDD/MDR typically refers to Medical Device Directives/Regulations. The Medical Device Directive (MDD) was a European Union directive that set the regulatory requirements for medical devices sold in the EU. It has been superseded by the Medical Device Regulation (MDR), which introduces stricter requirements for clinical evidence, post-market surveillance, and traceability of medical devices. The MDR aims to improve patient safety and ensure a high level of health protection. The terms are used to describe the legal framework governing medical device development, manufacturing, and distribution within the European market.

What other technologies are related to MDD/MDR?

MDD/MDR Complementary Technologies

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is strongly complementary to MDD/MDR as it provides a framework for compliance.
mentioned alongside MDD/MDR in 1% (94) of relevant job posts

Which organizations are mentioning MDD/MDR?

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