Proven Tested Technique
Proven, tested technology and its application to the body form Center Multiwell concept: About CE, CE, CE medical class I, CE class II, notified bodies etc. Here are a few notes/quotations and lesson to the look up and think: CE: through the affixing CE marking confirms the manufacturer that the product complies with the applicable European directives. CE marking allows no conclusions about whether the product has been reviewed by independent bodies on the compliance with the guidelines. The CE marking is not a seal of quality (quality mark). (Source: Wikipedia.de) Import from China and the regulations regulations? Yes, rules – for trade between China and Germany exist this to justice. As the global trade is not as clear as one might think. As an importer, one is forced to note many import restrictions and regulations.
This however happens in your own interest, because it is liable is not the manufacturer, but the one of a product, imports into the EU, or it there brings into circulation”. (Source: sourceit.de) Explanation CE number: A four-digit number is attached to the CE marking, this points to the involvement of a notified body in the conformity assessment procedure. (Source: Wikipedia.de) Places named notified bodies accredited bodies that verify the conformity of the manufacturing process on behalf of a manufacturer and their Korrektheit certify in accordance with uniform assessment standards are State-owned. Manufacturers can consult a notified body of their choice, which is named for the procedure and the relevant product category. (DIMDI source: dimdi.de) Under following link you will find places where you can find also a DNV (CE 0434) appointed EU ec.europa.eu/enterprise/… (Source: Nando, European Commission) Directive 93/42/EEC concerning medical devices Directive 93/42/EEC of 14 June 1993 concerning medical devices is a directive and is short in ermany and Austria as Medical device directive referred to. Internationally, one speaks of the directive as a medical device directive (MDD) under Directive 93/42/EEC. It is the most important regulatory instrument for the safety of medical devices in the European area. (Source Wikipedia.de)