Product compliance is much more than just laboratory testing. European importers, in virtually every industry, are obliged to issue certain documentation – to demonstrate compliance with all applicable product regulations.
Perhaps the most important of all documents is the Declaration of Conformity (DoC).
It’s a rather complex topic, so we decided to ask an expert. His name is Ferry Vermeulen, founder of INSTRKTIV.com.
In this article, Ferry explains what every EU based importer must know about drafting a Declaration of Conformity, and the various other documents you need.
Ferry, tell us a bit about yourself and Instrktiv.com
I am founder and director of business development at INSTRKTIV. After starting my own industrial design agency back in 2006, I co-founded the company Manualise in 2009.
As the CEO from 2009 – 2015, my content strategy brought the company over 15 #1 Google positions on main keywords like ‘creating user manuals’ which led to many international clients, such as Electrolux, AkzoNobel, Schneider Electric and Lid.
In 2016 I founded INSTRKTIV GmbH and moved from Amsterdam to Berlin. INSTRKTIV helps companies and brands to produce their technical documentation.
The company stands for content quality, both in the field of usability and liability: The manual as a legal document, which not only serves the keystone in terms of liability but also promotes safe and proper use, is at the core of this.
It makes me happy to help German and international companies developing appealing and compliant documentation which contribute to a better user experience.
In my ‘Man-Machine-Blog” I give hands on tips & techniques to improve the quality of content and improve the user experience. I cover topics like CE marking, the Declaration of Conformity (Read more) and Simplified Technical English.
The main document that an importer needs is a Declaration of Conformity. Can you please explain what this is?
Well, actually the Declaration of Conformity is ‘just’ the last document needed to be drawn up in order to complete the CE-marking process.
Figure 1: 6 steps towards CE marking
With the Declaration of Conformity, the manufacturer or importer declares that the product meets all applicable regulations.
The declaration needs to be drawn up, only when compliance of the product with the applicable requirements has been demonstrated.
Must the Declaration of Conformity follow a specific format?
The CE marking applies only to certain product groups. The kind of product determines which directives apply.
For example, on machinery, the Machinery Directive 2006/42/EC applies. But most likely also the EMC directive 2014/30/EU and the Low Voltage Directive 2014/35/EU apply.
On Toys, the Toy Safety Directive 2009/48/EU applies and on for devices with Wi-Fi, the Radio Equipment Directive 2014/53/EU apples.
Like each directive gives requirements on certain product aspects, they also give requirements on the content of the Declaration of Conformity.
Most directives have slightly different requirements regarding the content, but they almost all require to include information like the name and address of the manufacturer, the product name, type and serial number, used harmonized standards, place and date, the notified body involved (if any) and so on.
Depending on the applicable directives, it can be required to also include a color image, the name, and address of the person authorized to compile the technical file and/or the essential health and safety requirements with which the product complies.
There hardly is any flexibility on the information to include or not to include!
Who is responsible for creating a Declaration of Conformity, when importing goods from outside the EU?
Good question! The obligations of importers changed since the New Legislative Framework took over from the New Approach.
For the purposes of Union harmonization legislation, a product is placed on the market when it is made available for the first time on the Union market.
According to the legislation, placing a product on the market can only be done by a manufacturer or an importer. In other words: the manufacturer and the importer are the only economic operators who place products on the market.
The importer has clear obligations in relation to the compliance of products. Importers placing products from third countries on the European market (e.g. from China) are all considered to be producers under the Directive on product liability.
And when a distributor or an importer modifies a product or places the product on the market under their own name, they become the equivalent of the manufacturer – and must take on the latter’s responsibilities in relation to the product.
Who could possibly ask for the Declaration of Conformity?
Several types of entities could ask for the Declaration of Conformity.
First of all, as an importer you can ask the (i.e., Chinese) manufacturer to provide the Declaration of Conformity.
In many cases, a manufacturer from a country outside the EU draws up a document to fulfill the importer’s request, without being aware of all European legislation and without knowing if the products really meets all requirements.
But because the importer is held liable for the product imported, it is the importer who should check that the product really meets all applicable legislation and who accordingly should draw up the declaration of conformity.
b. National market surveillance authorities
According to the Directives, Member States should take measures to ensure that products may be made available on the market only if they comply with the essential requirements as set out in the directives.
In daily practice, this (amongst others) means that the so-called market surveillance authorities inspect if products meet the requirements.
They can do this randomly, but mostly when they have reasons to believe that a product presents a risk to the health or safety of persons.
At the disposal of the national market surveillance authority, the Declaration of Conformity needs to be provided.
The authority uses the Declaration of Conformity to check if the product really meets the directives and harmonized standards as declared on the Declaration.
Now and then even a well-informed consumer might ask for the Declaration of Conformity.
To prevent any problems of Products being recalled, products being returned by customers, customer claims and complaints, retailers more and more often request for evidence of product compliance.
Documentation like the Declaration of Conformity, technical file, user manual et cetera.should be well managed to be provided upon request
In addition to the Declaration of Conformity, the Importer must also create a Technical File. Which documents are included in the Technical file?
This strongly depends on the kind of product, but in general, it can be said that the Technical File should contain all information to prove that the product meets the essential health and safety requirements.
This can include (but not limited to):
- Any warnings and the user manual
- The declaration of conformity
- The risk analysis
- A description of the product
- The safety assessment carried out
- A description of the conformity assessment procedure
- Address of manufacture and storage
- Test reports
- Copies of documents submitted to the Notified Body
- EC-type examination
- A checklist of the safety requirements
Must these documents be written according to any specific format?
Like for the declaration of conformity, the kind of product and thus the applicable directive determines what exactly should be included in the Technical File.
For the Risk Analysis, harmonized standards exist, like the EN-ISO 12100:2010 Safety of machinery – General principles for design – Risk assessment and risk reduction.
For the user manual, there is the harmonized standard EN-IEC 82079-1:2012 Preparation of instructions for use – Structuring, content, and presentation.
Although applying a harmonized standard is not perse mandatory, compliance with harmonized standards provides a presumption of conformity with the corresponding requirements of directives.
Harmonized standards can be used to demonstrate that the products, services or processes comply with relevant EU legislation.
What is the Risk Assessment for?
Risk assessment is the process to identify hazards, analyze or evaluate the risk associated with that hazard and determining appropriate ways to eliminate or control the hazard.
When risks have been identified, according to the EN ISO 12100 risks can be reduced in the following order:
- Improve the design
- Take safety measures
- Provide information (warnings, instructions)
Are third party test reports mandatory?
This also this depends on the directive. A directive can require that the conformity assessment procedure needs to be carried out by a third party (notified body).
We have received many inquiries regarding the General Product Safety Directive (GPSD). Could you tell us a bit more about this?
The General Product Safety Directive covers all products which are not subject to other directives. The GPSD aims at ‘ensuring that only safe consumer products are sold in the EU’ which basically means that all products need to be safe.
For example, there are no specific directives for furniture, gymnastic equipment, bicycles or floating air mattresses.
That does not mean that these products are always safe.
To protect the public from any risks, the products need to comply with the GPSD and should be safe.
To meet the requirement of ‘being safe’, for most products harmonized standards have been developed, like the EN ISO 4210-1:2014 Cycles – Safety requirements for bicycles.
These standards describe technically how to meet the GPSD.
Products that fall within the General Product Safety Directive (GPSD) are not required to have a Declaration of Conformity or technical file.
However, instructions for the safe use of a product are required, even as it is required to give the public access to information on product identification, the nature of any risks and the measures are taken.
How can Instrktiv.com help Startups and Small Businesses importing from China?
We can help companies with:
- Supporting in the process towards CE-marking and consulting on the legal requirements; (Read more)
- Creating user manuals and other relevant technical documentation (Read more)
- Providing software and training to manage content; (Read more)
- Offering temporary capacity for the creation of your documentation. (Read more)