MDD 93/42/EEC Medical Device Classification

[J0anne]

93/42/EEC states that devices shall be divided into Classes I, IIa, IIb and III.

So the question is, how and why did Notified Bodies reach the conclusion that we can also have a Class Is and a Class Im? (for both sterile and measuring)

Thank you.

 

[Marcelo]

Due to ANNEX VII Item 5.

5. With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Annex but also one of the procedures referred to in Annex II, IV, V or VI.

Application of the abovementioned Annexes and the intervention by the notified body is limited to:
? in the case of products placed on the market in sterile condition,

- in the case of devices with a measuring function, only the aspects of manufacture concerned with the conformity of the products with the metrological requirements.

 

[Ronen E]

93/42/EEC states that devices shall be divided into Classes I, IIa, IIb and III.

So the question is, how and why did Notified Bodies reach the conclusion that we can also have a Class Is and a Class Im? (for both sterile and measuring)

Thank you.

Hi,

In my understanding those are not official classes. The official class would be I. The "s" and "m" are used for highlighting the NB involvement (as opposed to plain class I), as prescribed in the MDD for class I devices which are intended to be sterile and/or have a measuring function.

This notation is widely used throughout the industry and regulatory bodies, although it has no legal force in itself.

Cheers,
Ronen.

 

[Marcelo]

And what Ronen said .