Understanding European Declarations of Conformity or Incorporation

Certificate of Conformity

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.

List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Updated

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.

List European Harmonized Standards for the ATEX Directive (94/9/EC) Updated

On Friday 4 May 2012, the European Commission published an updated list of the European harmonized standards that pertain to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres. The standards on this list may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive. The list introduces two new European harmonized standards: 1. EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. This standard replaces the 2004 version with the same number. By 30 September of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity. 2. EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). This standard replaces the EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006. By 4 August of 2014 the new standard must be applied in order to keep benefiting the presumption of conformity. This updated list is also important to all manufacturers of CE marked ATEX that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. The updated list of standards can be found in our Library shortly.

Video: Two examples of the Declaration of Conformity

Do you know what a Declaration of Conformity looks like? Do you know what format is has?

In this video, I show two examples of Declarations of Conformity I came across just recently. The examples illustrate how the Declaration of Conformity can be kept small and even serve multiple purposes.