VdTÜV Portal

Medical Devices

For a secure and transparent medical devices' legislation
Gesundheit-Medizin-Medical Device
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Medical devices are used for medic-therapeutic or diagnostic purposes for human beings. They differ greatly from drugs in their mode of effect, and are not comparable with them. Medical devices have a physical or a physic-chemical effect, and pharmaceuticals have a pharmacological, immunological or metabolic effect.

In Europe, medical devices can only enter the market with a CE marking, which is a self-declaration by the manufacturer. Thus, the manufacturer is responsible for the placing of products on the market. By affixing the CE marking, the manufacturer declares that the product complies with the relevant provisions of existing directives, in particular with essential requirements.

Depending on the risk potential of products, it is intended that conformity assessment procedures are the sole responsibility of the manufacturer or with the involvement of a Notified Body – for example a TÜV organisation. The Notified Body is an independent testing and certification body that verifies the conformity assessment performed on behalf of the manufacturer, and certifies its correctness according to standard assessment factors.

Independence and competence of the Notified Body is usually ensured by national accreditation as a mandatory responsibility. The designation and monitoring of Notified Bodies is carried out by the relevant authorities of the EU Member States.

VdTÜV particularly advocates legally secure and transparent medical devices legislation as well as Europe-wide uniform and high standards for Notified Bodies and the conformity assessment procedures to be performed.

VdTÜV offers some background information on the topic of medical devices. These can be found below for download.

German Association of Notified Bodies for Medical Devices

News

Agreement reached on new European medical devices legislation

New provisions for medical devices and in vitro diagnostics have been decided at the informal trialogue on 25 May 2016. The regulations provide for a tightening of the rules for placing medical devices on the market and for more stringent monitoring after their market launch.