This course provides you with a method to apply to decide what level of diligence is appropriate and what scope that diligence should have.
CE marking originated in 1985 and regards a certification mark that nowadays is a crucial aspect for many products on the European market. The main focus of the EU directives is on health, safety and environmental protection. Simply put, the EU uses the CE marking to guarantee safe products are placed on the internal market.
The symbol is distinguishable by its large C and E. Many people believe these letters stand for China Export. This is a wrong conception. The letters are an acronym of the French Conformité Européene, which translates to European Conformity. In short, the symbol indicates that a product adheres to the regulations and directives set up by the European Union.
There are many purposes to CE marking. Companies and consumers both benefit from the certification.
Companies benefit greatly from the mark as it is recognised worldwide and proves a company put a safe product on the market. A manufacturer can move the product freely across the single market once a CE Mark is put in place, enabling easier trading both in the EU and on an international level.
At the same time, the mark safeguards fair competition. The same rules apply to all companies within the European Economic Area, rather than there being significant differences across countries.
For customers there are great benefits too. The most prominent one is that safety and health is guaranteed. This is especially relevant in terms of medical supplies or electronics, such as smartphones. At the same time, the products on the internal market comply with the minimum environmental standards of the EU, which has great value to many customers.
The relevance of the mark for customers again translates to an advantage for companies. Having the CE marking is of great value for sales, because customers recognise the mark and regard it as a symbol of safety, ensuring they feel more comfortable when purchasing the product.
There are more than 20 regulations and directives that are relevant to CE marking. Of course, not every product will deal with each single directive. Complying with EU legislation, therefore, means something different for each product.
For instance, machinery deals with directives such as the Machinery Directive, the Low Voltage Directive, the EMC Directive and the Pressure Equipment Directive. Toys on the other hand have to meet the standards drawn up in the Toy Safety Directive, which focuses on making toys safe to use for children to play with. Steel products have to comply with the Construction Products Directive and medical devices, such as appliances used in hospitals, are required to meet the Medical Devices Directive.
We’ve written an article on some of the most important CE marking regulations and directives for products like these.
When dealing with the directives, a manufacturer could make use of the harmonised standards. These standards serve as a foundation for companies to comply with the requirements laid out by the EU. Although the harmonised standards are not obligatory, they provide a great route to conformity.
An important piece to point out is the Construction Products Regulation, often abbreviated to CPR. This regulation clarifies how to affix the mark to construction products, what the exact rules are for construction products, what the role is of all bodies relevant to this group of products and what the framework can be used for adhering to EU law. Safety regulations put in place deal with for example safety in case of a fire and noise pollution.
One directive that is managed separately by the European Commission is the Restriction of Hazardous Substances Directive (RoHS). This directive aims itself at electronic and electrical equipment and was agreed upon to reduce the amounts of toxic electronic waste coming from substances such as lead and mercury.
The initial directive of 2002 was replaced with the new so-called RoHS 2 directive in 2011. The RoHS 3 of 2015 has even expanded on that directive, adding 4 new prohibited substances.
As the RoHS are a separate matter, RoHS Certification has been made available. This certification straightforwardly proves a product adheres to the rules laid out in the directive.
Often confused with the RoHS is REACH. This regulation stands for Registration, Evaluation, Authorisations and Restriction of Chemicals. This regulation, in contrast to the RoHS, focuses on registering data and evaluating safety of products both old and new.
There are different steps to take before you are legible to receive the CE marking. You can decide to go through the CE marking process yourself, but it is recommended to use an expert as dealing with the different regulations and directives can be a convoluted matter.
The first step to take is to look at what directives are applicable to your product. From there on out it’s important to check whether the product already complies with these rules. It might be the case that you needn’t change anything about your product for conformity.
If your product does require changes, the product should be adapted so it complies. Next follows testing your product and compiling proof that your product actually meets the demands. The final steps are to draw up a Declaration of Conformity and properly affix the CE mark to your product.
Some products require the use of a so-called Notified Body. This body comes into play when certification is required for products with higher risks. The Notified Body is an independent organisation, which will test your product.
The Declaration of Conformity is a mandatory document that includes:
Signing this document means a representative or organisation states it delivers a product that meets the minimum requirements. For the European Commission this means an individual can be held accountable if the product in the end does not adhere to the EU legislation.
There are declarations for each product group, but the declarations are especially relevant for medical devices. A Declaration of Conformity on Medical Devices has the same mandatory pieces as stated above.
The Declaration of Conformity can be easily confused with the General Certificate of Conformity. This certificate is applicable to the US and not the UK.
The length of the entire CE marking process differs greatly across products. On average it takes roughly 6 to 8 weeks per product. When, after testing, a product has to be modified, the process will take longer. High-risk products will also take longer to be certified and might take roughly 12 to 16 weeks.
The pricing of CE certification differs greatly across products. The largest part of the budget will go to testing and making use of consultants as well as certification bodies. The more of these you need, the more expensive the certification becomes. Expect at least a few thousands to go through the entire process unless you make use of self-certification.
Fortunately, there are other options for smaller businesses. They can request a great number of companies for funding. Different parts of the process can be funded. Normally funding can be received for approximately 50% of the costs.
There’s a little more to the mark than just fulfilling the obligations for the product itself. The EU also monitors how the CE marking appears on your product.
First off, the mark itself has to be visible, legible and indelible, so the CE mark can always be seen properly by any requesting it. In some cases, the symbol cannot be affixed due to the nature of the product. In this case the mark should appear on the packaging (if there is any) and the accompanying documents.
Important to note is that the mark can only be affixed to those products that require the labelling. It is in fact illegal to place the mark on a product if it does not need one.
There are 20 groups of products that require CE certification. These are often products at risk of causing health or safety problems. Amongst these are machinery, medical devices, lifts, measuring instruments and explosives for civil uses. Find a full list of all products in our piece on CE certification.
However, there are exemptions to these product groups. For instance, not every machine requires the CE certification. One example is machinery that is designed and constructed for research purposes for temporary use in a laboratory.
Besides fulfilling the legal obligations, the mark’s relevance extends beyond the EU. As mentioned before, the certification is significant for international trade. Companies wishing to place their product on the European market have to take the legislative pieces into account.
Similarly to the process manufacturers in Europe have to follow, companies from for instance Australia or India looking to export to Europe, will need to follow the different steps in the CE marking process to reach conformity. This is a requirement if they wish to export to countries within the European Economic Area (28 member states of the EU and Iceland, Norway and Liechtenstein) as well as Switzerland.
Enforcement of the mark is tiered. Different individuals have their own responsibilities to ensuring products meet the EU requirements.
Whereas the manufacturer has to guarantee their product is safe to use for at least 10 years, an employer has to properly maintain and inspect a product. The importer and the distributor have to ensure products traded across countries all have the proper CE marking in place and have the valid proof that they adhere to the regulations and directives. Distributors also have to be able to prove they handled the products properly and according to EU legislation.
It differs per country how CE marking is enforced. Each member of the European Economic Area has their own Market Surveillance Authorities. If a manufacturer, importer, distributor or employer fails to meet the EU standards, one of these authorities can choose to send a financial penalty, prohibition notice and/or product recall.
For countries outside the EU there are European Authorised Representatives. These representatives are neutral intermediaries and ensure a manufacturer has held up their end of the bargain and met all requirements.
Along with the CE marking, you may also find the Kitemark on products from or inside the UK. The Kitemark, like the CE mark, is put in place to guarantee safety. The certification symbol is present on products, such as alarm systems and helmets.
The Kitemark was put in place in 1903, well before CE marking legislation was drawn up by the EU. Obtaining the Kitemark is done solely via the BSI Group, which assesses products and grants or denies a company a licence.
The big difference between the Kitemark and the CE marking is that the Kitemark is not mandatory. It serves as a way for companies to demonstrate the safety of their products within the UK.
Simply put, the BS EN standard is the British adoption of a standard set out by the EU. BS in this case is an acronym of British Standards, which are the responsibility of the aforementioned BSI Group. EN stands for European Norm.
The combination of BS and EN means European standards have been combined with British standards to adapt them to the UK’s economic climate. In several cases, the BSI was forced to withdraw British standards if they conflicted EU standards. This is due to the fact that EU law trumps national law in all cases.
Always make sure to stay up to date with new legislative pieces. Be aware changes may occur post Brexit.