EU Medical Device Regulation (MDR) 2017/745 Fundamentals Training Course
Level of Difficulty
Basic (A very basic knowledge of the topic but no professional usage).
This practical and interactive 2-day course focuses on what is required to bring a Medical Device to market under Medical Device Regulation (EU) 2017/745 (MDR).
On April 5, 2017, the Medical Device Regulation (EU) 2017/745 replaced the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The Medical Device Regulation entered into force on May 25, 2021, after a four-year transition period. EU MDR compliance is accomplished by demonstrating conformity with all relevant aspects of the Medical Device Regulation (EU) 2017/745. Manufacturers will need to demonstrate compliance to gain regulatory approval of their medical devices.
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