MDR (EU Medical Device Regulations)


EU MDR Regulations
The new Medical Devices Regulation (EU) 2017/745 (MDR) will bring EU legislation into line with technical advances, changes in medical science and progress in law-making. Read the MDR here:
EU MDR Distributor Compliance Manual for MDR
This Manual is intended for Tricefy distributors located in the EU region. The purpose of this Manual is to provide instruction and guidance for complying with the EU Medical Device Regulation
Standard Operating Procedure 22: Distributors
The purpose of this Standard Operating Procedure is to establish the process for creating and managing Distributors, who sell, install and support Tricefy in their respective markets
EU MDR Complaint Form
PCF-01-A8 Complaint Form.pdf Complaints are written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device that has been release...