top of page
Icologiq Knowledge ยท Regulation
EU Medical Device Regulation
The European Union regulation governing medical devices, including requirements for safety, performance, quality systems, clinical evidence and post-market activities.
EU MDR
Also known as:
MDR, Regulation (EU) 2017/745, Medical Device Regulation
At a glance
Definition
The EU Medical Device Regulation establishes the legal framework for placing and maintaining medical devices on the EU market. It covers manufacturer obligations, conformity assessment, technical documentation, quality systems, vigilance, post-market activities, traceability and other requirements depending on the device and economic-operator role.
Why it matters
EU MDR is essential MedTech terminology and provides direct connections to compliance management, document control, CAPA, audit, risk and change.
MED-003
The European Union regulation governing medical devices, including requirements for safety, performance, quality systems, clinical evidence and post-market activities.
The EU Medical Device Regulation establishes the legal framework for placing and maintaining medical devices on the EU market. It covers manufacturer obligations, conformity assessment, technical documentation, quality systems, vigilance, post-market activities, traceability and other requirements depending on the device and economic-operator role.
bottom of page