Making a Declaration of Conformity for CE Marking in Europe? Avoid 5 common mistakes.
Whilst making a Declaration of Conformity is a common activity for many manufacturers, there are a number of common mistakes that can be avoided.
30 December 2014
A Declaration of Conformity (DoC) is required in the EU, to indicate the mandatory compliance of certain products types with the requirements governing them. Once a manufacturer has made a DoC, CE Marking can be applied to the product. So every manufacturer knows how to make a DoC? Not necessarily, sometimes manufacturers get it wrong. Here are the top 5 mistakes to avoid.
Not making a Declaration of Conformity - Manufacturers of products entering the EU market for the first time sometimes don’t realise that they have to make a Declaration of Conformity and apply CE Marking to their product. This is a common omission when distance selling over the internet to EU customers for example.
https://www.gov.uk/ce-marking#products-that-need-ce-marking has an excellent summary of the products that CE Marking applies to.
Making a Declaration that doesn’t cover all of the applicable EU Directives - By making a DoC, a manufacturer declares compliance with ALL applicable Directives that govern their product. This can be many more than some organisations are aware of. ‘The Blue Guide on the implementation of EU product rules’ published by the EU Commission (it’s easy to find on Google), identifies nearly thirty Directives that might need to be considered, covering everything from materials to energy consumption to safety.
Not having someone of suitable authority sign the Declaration – The person that actually signs the DoC, is personally responsible for the compliance of the product. An understanding of the product assessment process and the necessary authority to take corrective action if there turns out to be a problem, is appropriate for the signee who will be the first point of contact for the surveillance authorities.
Not including enough data in the Declaration to enable good traceability - Product traceability ensures manufacturers are accountable for the compliance of their product. Whilst not all non-compliance is dangerous to the product user, all non-compliance requires corrective action to bring the product into compliance. Adequate contact data needs to be included on the Declaration so the manufacturer can be easily reached by the surveillance authorities and identifying product information like a serial number/batch/model number helps to identify issues in specific groups of products.
Not including in the name and identification number of the Notified Body that performed their conformity assessment- Manufacturers often use recognised experts called ‘Notified Bodies’ to assess their products - giving them independence evidence to support their Declaration. Each Notified Body has an identifying number, which should be included in the Declaration for easy verification.
More information on CE marking can be found here: http://ec.europa.eu/growth/single-market/ce-marking/
Natasha Moore, PR & Marketing Manager at Intertek’s product testing facility in Leatherhead, is a 10-year testing and certification industry veteran and author of numerous Intertek technical papers on product assessment and market access.