Atención que incluye diversos cambios que ayudan a clarificar en la guia, pero sin cambios en la regla 11 donde si iria bien que se pusieran mas ejemplos de lo que aplica o no a estos softwares medicos …
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MDCG 2021-24 Rev 1 changes |
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2.1 General requirements |
Updated |
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3.1.4 Invasiveness – Implantable devices |
Word ‘surgical’ was replaced with ‘clinical’ |
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3.2 Application of the classification rules |
Word ‘device’ was replaced with ‘product’ |
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4.1.3 Active devices – Rule 9 |
Structure changed to better match the rule |
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Rule 2 – Table |
Updated |
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Rule 8 – Table |
Updated |
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Rule 8 – Practical issues of classification |
Updated – new notes added (1-7) |
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Rule 9 – Practical issues of classification |
Updated |
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Rule 10 – Table |
Updated |
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Rule 10 – Practical issues of classification |
Updated |
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Rule 12 – Table |
Updated |
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Rule 16 – Table |
Updated |
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Rule 22 – Table |
Updated |
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Rule 22 – Practical issues of classification |
Updated – new note added |
MDCG 2021-24 rev1
Tambien se ha acttualizado el manual de clasificación de productos frontera (borderline)
Borderline manual 2026-04
Nota sobre manual borderline 2026-04
