MDR Definitions

Manufacturer
”‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;”

Notified Body
”‘notified body’ means a conformity assessment body designated in accordance with this Regulation;”

Click here for an overview of Notified Bodies. 

Competent Authority
”‘competent authority’ means the authority or authorities responsible for performing the tasks related to the regulation of devices in the Member State;”

Conformity Assessment
”‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;”

Post-market Surveillance (PMS)
”‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;”

Vigilance
”‘vigilance’ means the activities related to the detection, reporting and analysis of serious incidents and field safety corrective actions;”