MDCG 2021- 24 - Ottobre 2021
Il Medical Device Coordination Group (MDCG), composto da rappresentanti di tutti gli Stati membri e presieduto da un rappresentante della Commissione Europea, ha approvato il documento MDCG 2021- 24 Guidance on classification of medical devices.
Il documento riporta esempi delle classi di rischio da attribuire ai diversi dispositivi medici in conformità all'Allegato VIII del Regolamento (UE) 2017/745.
Raccolta Linee guida MEDDEV Dispositivi medici Rev. 25.0 del 16.10.2021
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Table of contents
1 Purpose of medical device classification
2 Practical relevance of classification
2.1 General requirements
2.2 Conformity assessment
2.3 Clinical evaluation and investigation
2.4 Post-market surveillance
2.5 Traceability
2.6 Instructions for use
3 How to carry out classification
3.1 Basic terms and definitions
Specific medical purpose
Duration of use
Continuous use
Invasiveness
Active medical devices
Devices with a measuring function
Systems and procedure packs
Other terms
3.2 Application of the classification rules
How to use the rules
Practical example
3.3 Handling of interpretational problems
4 Explanations of individual rules
4.1 Graphical summary
Non-invasive devices
Invasive devices
Active devices
Special rules
4.2 General explanation of rules/practical issues/examples
Non-invasive devices
Invasive devices
Active devices
Special rules
...
Fonte: EC
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