CEN, the European Committee for Standardization published three new European Standards, which come to help improving the safety of internal window blinds and reduce risk to children. These standards are aimed in particular at reducing the risk of accidents associated with the cords that are used to operate window blinds.
In order to understand the various types of EU Declarations, it’s important to first understand a bit about the system that uses them. Two systems of product safety evaluation are currently in wide use globally: Certification, and Marking. Understanding the differences between these two systems is important for anyone who gets involved with regulatory compliance activities. It’s also important to know that these Declarations have no relationship to the compliance declarations often used in commercial supply chains. Supply chain declarations are simply used to ensure that vendors attest to the fact that they supplied what the customer ordered. This type of document has no relationship to the EU Declarations discussed article.
On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive.
The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.
Have you been struggling with the question what information has to be included in the EC Declaration of Conformity? And in what format the document should be? Have you been searching for the CE marking logo to put on your product? This package provides you an easy editable template of the Declaration of Conformity in the correct format. And we included the CE logo in various graphical file formats. A download link for the package is delivered immediately upon order. In 5 minutes you’ll be ready. And you’re sure that your template is correct and complete.