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VDE-AR-E 2750-200 Anwendungsregel:2013-03

* German Language Version *

Approach to the classification of medical devices and the selection of conformity assessment procedure

Class/Status: Anwendungsregel, valid
Released: 2013-03
VDE Art. No.: 0750219

Contents

In the development of devices and systems for applications in the field of Ambient Assisted Living (AAL) it has to be decided in many cases whether they are to be classified as a medical device and which is the procedure to be selected for conformity assessment. It must first be clarified whether the device or system is to be classified as a medical device. The answer can be found in clause 4 of the application guide.
If the device or system falls under the medical device definition it is classified according to Annex IX of the Directive 93/42/EEC. This is illustrated in clause 5 of the application guide.
The further procedure depends on the assigned class. The methods to be applied are described in clause 6 of the application guide, further requirements are given in clause 7.