Active implantable medical devices directive (AIMDD) does not require any kind of classification. 

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In vitro diagnostic devices (IVD) are classified according to lists A or B in Annex II to IVDD.

• List A contains those products intended to determine blood groups (ABO system, rhesus (C, c, D, E, e) anti-Kell, and those for the detection and confirmation of markers of HIV infection (1 and 2), HTLV (I and II) and hepatitis (B, C, and D).

• List B contemplates all other cases.

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Medical Devices Directive (MDD) classifies medical devices into 4 groups ranging from low risk to high risk, those are:

• Class I devices are considered to be low risk devices. Though it is true that those may have a measuring function and/or need to be sterile, which are then considered to be Class Im or Class Is, respectively, and are considered to be of low-medium risk.

• Class IIa devices are considered to be of medium-low risk.

• Class IIb devices are considered to be of medium-high risk.

• Class III devices are considered to be of high risk.

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This classification is done through 18 rules set out in Annex IX to MDD, the rules follow the order: non-invasive devices, invasive devices, additional rules applicable to active devices and special rules. Moreover, at the beginning some implementing rules are defined in order to obtain the best and strictest classification.