Updates to the MDCG Guidance on Classification of Medical Devices
MDCG 2021-24 rev.1 Guidance on classification of medical devices has been updated. Among the updates are:
In Section 3.1.4 concerning invasiveness of implantable devices the word “surgical” is replaced by “clinical”
In Section 3.2 Application of the classification rules, the word “device” has been replaced by “product”
The structure of Section 4.1.3 concerning active devices has been changed to better reflect Rule 9
Rule 22 - Practical issues of classification has been updated with an additional note. This note provides guidance that, in the majority of cases drops would only enter the ear as far as the ear drum. This is regarded as applied to the skin and has its action locally. Consequently the device would be class IIa
Update to Rules 2, 8, 9, 10, 12, 16