Understanding Harmonized Standards and CE Marking

Introduction to CE Marking 

The CE Mark allows manufacturers to import and export their products freely within the European Union, with common product design and manufacturing requirements defined within EU directives and/or regulations. By placing the mandatory conformity mark on a product, manufacturers are providing a clear indication that it meets all the requirements of relevant CE marking directive/regulation and therefore should enable free movement within the EU. 

CE marking applies to numerous different product categories, ranging from electrical equipment to explosives and from toys to medical devices. Each product falls under one or more directives or regulations, which determine the specific requirements that the product must meet to be CE-marked. The manufacturer is responsible for ensuring product compliance and placing the CE mark on the product before it’s placed on the market. 

The CE Mark does not represent a product has undergone safety testing but rather is a self-declaration from the manufacturer that it meets the directives and regulations that apply to it, thereby achieving one of the EU’s primary objectives of a single market. To achieve this, the manufacturer must carry out a full risk assessment of the product against the ‘essential requirements’ of the directive/regulation. The initial stage of this assessment, the risk analysis, is the process of identifying all the potential hazards associated with the product and the environment in which it is going to be used. 

Many of the hazards identified in a risk assessment will be covered by the application of one or more applicable harmonized standards; European standards that have been developed by a recognized European Standards Organisation and cited in the Official Journal of the European Union (OJEU). 

Presumption of conformity

By testing to a harmonized standard or standards, published in the OJEU, manufacturers can demonstrate that a product complies with the essential requirements of the directive and gain a ‘presumption of conformity’. 

As part of the process, the manufacturer is responsible for carefully considering each potential hazard against the essential requirements of the applicable directive(s) and being able to provide clear evidence of having done so. This includes considering not only the use but also potential misuse of the product.  

Whilst the duty to carry out a full risk analysis lies with the manufacturer; Element’s experts can provide in-depth advice and support in working through the details of the risk analysis. Each risk identified must have its impact assessed, termed a risk evaluation. This evaluation, combined with the risk analysis, is the risk assessment. 

If the assessment finds that the risk is high, additional action is then required to reduce the risk to a more acceptable level. This can be done by performing additional tests to simulate the risks or modifying the design of the product to eliminate the hazard.

Selecting and applying the most appropriate harmonized standard

As not all hazards will necessarily be covered in this process, the application of a harmonized standard on its own is not always sufficient for demonstrating compliance. The manufacturer must select and apply the most appropriate harmonized standard, assess if the standard is fully adequate for the product and its environment, and also determine if the product requires additional tests before it can be placed on the market.

The references of harmonized standards are published in the OJEU, which a manufacturer should use as the first point of call when selecting the appropriate harmonized standards to test a product. However, as testing to the latest and most relevant standards is vital, it usually requires the manufacturer to check elsewhere for more applicable standards yet to be published in the OJEU Journal. Standards organizations such as ETSI and CENELEC are invaluable at this stage as they provide insight into the working of future standards which may include identification of new hazards previously not considered. 

It is worth noting that using harmonized standards is one of the two main routes to CE marking, in most directives it is completely voluntary with manufacturers able to decide on the best route for their product and choose other ways to fulfill the essential requirements if preferred.

If there are no harmonized standards for article 3.2 aspects (the RF characteristics) then it is mandatory to go to a Notified Body for a Type Examination Certificate. This is where the Notified Body independently assesses what has been done, checking that the technical documents are compiled properly and presented in a way that demonstrates that the essential requirements of the directive have been met. It should be noted that there may be other reasons why a manufacturer wishes to use the TEC route, including confirmation that they have applied the right standards.

If the manufacturer is using standards that are not listed in the OJEU then they must not forget to add additional time to the compliance process if they are using a Notified Body. While using a Notified Body will inevitably add time to market, it also identifies administrative mistakes that may be picked up by market surveillance authorities later on.

Ensuring ongoing compliance

As new technologies and hazards are identified, harmonized standards evolve and are either amended or revised accordingly. Therefore, it is vital that manufacturers understand their duty to ongoing compliance for their products and keep fully informed of any changes to their product’s relevant standards. When a standard is updated, there would normally be a transitional period where a manufacturer has time to upgrade their compliance information with results from the new standard before the previous version is withdrawn from the OJEU and presumption of conformity is no longer justified.

Considering CE marking from day one of the design processes 

Achieving compliance to gain the CE Mark can be a complex process due to the different requirements of individual standards, especially when applied simultaneously. Each standard has a scope, which describes in detail the types of products to which it applies. The scope is often open to interpretation which can create confusion for manufacturers trying to decide which standard(s) applies to their product. Also, there are often overlaps with other legislation and specific exclusions for some product types. 

Unless a manufacturer has a comprehensive understanding of their responsibilities and how to meet them, they must seek expert advice to reduce ambiguity on CE marking requirements. 

As a Notified Body, Element can provide expert guidance to support products through the relevant testing process. Manufacturers often reach out to Element for the first time at the end of a product’s development process to start discussing CE testing, but the reality is that a product would be lucky to pass with no prior foresight into the tests or specifications. To have a successful outcome, it is much easier if the conversation is started earlier in the product’s life-cycle so that any design requirements that are necessary to meet the applicable standard can be built into the product from day one of the design processes. This will not only prevent delays but can guard against the significant costs associated with product modifications.

If you would like to find out more about CE marking a device or request a quote, please contact us today.