Regulatory, quality and clinical affairs
NX-451
Preparation work for 27.02.2025
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Description
During the 27.02.2025 class we will study the concept of classification of Medical Device as well as introducing the General Safety and Performance Requirements. Please complete these two tasks
Page content
1) Read through Annex VIII Classification rules
Annex VIII of the MDR outlines the classification rules for medical devices based on their inherent risks, intended use, and characteristics. Devices are categorized into Class I (low risk), Class IIa (medium risk), Class IIb (higher risk), and Class III (highest risk). Correct classification is crucial as it determines the level of regulatory scrutiny and conformity assessment required before CE marking and market approval in the EU. The classification concept will be reviewed during the class and the Annex will be used for the classification exercises.
To do:
- Download the MDR (link in General section)
- Go to section VIII Classification rules (Page 140)
- Read through the complete Annex VIII to get familiar with the content
The General Safety and Performance Requirements (GSPR) in Annex I of the Medical Device Regulation (MDR) (EU) 2017/745 outline the essential criteria that medical devices must meet to ensure safety, performance, and regulatory compliance. Meeting the GSPR is mandatory for obtaining CE marking and placing a medical device on the EU market
The GSPR will be reviewed during the class and the Annex will be used for the GSPR Matrix exercise.
To do:
- Download the MDR (link in General section)
- Go to Annex I General Safety and Performance Requirements (Page 94)
- Read through the complete Annex I to get familiar with the content