The Medical Device Regulation entered into force on 25 May 2017 and became applicable on 26 May 2021. Catheters are just as much medical devices as pacemakers or X-ray machines are.
Medical devices may only be placed on the European market when they have a CE marking – so a self-declaration by the manufacturer. By displaying the CE marking, manufacturers declare that their product complies with the relevant provisions of the applicable legal requirements (conformity). For medical devices with a certain risk potential, a Notified Body such as a TÜV organisation is involved as an independent testing and certification body in the conformity assessment procedure. During a conformity assessment, the auditors from the Notified Body check whether the medical device actually complies with the relevant requirements.
The TÜV-Association is committed to transparent legislation for medical devices that is legally incontestable. It calls for stringent uniform requirements throughout Europe for Notified Bodies and the conformity assessments to be carried out.
IG-NB German Notified Body Alliance
The TÜV Association oversees the German Notified Bodies Alliance IG-NB (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland). The IG-NB aims to develop common positions, coordinate the interests of the German Notified Bodies and better enforce these vis-à-vis industry and the authorities.