Your Complete Guide to CE Marking Compliance FAQs

Your Complete Guide to CE Marking Compliance FAQs

11th November 2020

The New Legislative Framework initiative adopted in 2008 across the European market aims to protect employees and consumers from unsafe products hence boosting the quality of conformity assessment. CE marked fabrications act as a declaration from the manufacturer that the products meet the relevant health and safety requirements as per the appropriate European legislation and have passed the necessary conformity assessment procedures. Below are common CE marking FAQs and respective detailed explanations.

Do You Need CE Marking for All Your Products?

No. You’ll need to apply CE marking only for the products specified by the New Approach Directives. These products include electronic equipment, construction products, cableways, lifts, hot water boilers, explosives meant for civil use, equipment used in explosive environments, gas appliances, machinery, toys, pressure equipment, basic pressure vessels, recreational craft, telecommunications terminal equipment, radio, personal protective equipment (PPE), medical devices, measuring instruments, and non-automatic weighing instruments. Note that placing a CE mark on products not covered by the directive is illegal.

What are the New Approach Directives?

These directives define the critical requirements that must be met when designing and manufacturing products to be released into the market. However, the directives do not provide technical specifications that manufacturers should follow to meet the requirements. Therefore, the manufacturers can decide to apply harmonised standards or other standards to comply with the directives’ requirements. For some products, you may need to apply more than one directive for compliance. Below is the list of the New Approach Directives:

  • Construction Products – Regulation (EU) No 305/2011

  • Lifts – Directive 2014/33/EU

  • Civil Explosives – Directive 2014/28/EU

  • ATEX – Directives 2014/34/EU

  • Measuring instruments – Directive 2014/32/EU

  • Basic pressure vessels – Directive 2014/29/EU

  • Non-automatic weighing instruments – Directive 2014/31/EU

  • Cableways installations – Regulation (EU) 2016/424

  • Pyrotechnic articles – Directive 2013/29/EU

  • Gas appliances – Regulation (EU) 2016/426

  • Personal protective equipment (PPE) – Regulation (EU) 2016/425

  • Active implantable medical services – Directive 90/385/EEC

  • Low Voltage –Directive 2014/35/EU

  • Toy safety – Directive 2009/48/EU

  • Transportable pressure equipment – Directive 2010/35/EU

  • Marine Equipment – Directive 2014/90/EU

  • Recreational craft and personal watercraft – Directive 2013/53/EU

  • Radio Equipment – Directive 2014/53/EU

  • Eco design-hot water boilers – Directive 92/42/EEC

  • Restriction of hazardous substances in electrical and electronic equipment – Directive 2011/65/EU

What Does Conformity Assessment Mean?

This refers to the process used by manufacturers to demonstrate if a particular requirement relating to a specific product has been met. Normally, the manufacturers have to subject the products to conformity assessment both during the design and manufacturing phases, regardless of whether the manufacturers are directly involved in the design and manufacturing process or they use subcontractors. Manufacturers have several conformity assessment options to choose from based on the relevant legislation. The EU representative or the manufacturer needs to maintain a technical file and make necessary arrangements for inspection and control purposes from the national authorities. These files usually contain all the necessary information for demonstrating the conformity of the products to the relevant requirements.

Will everything be good after the CE Marking?

CE marking will be valid provided your products meet the relevant health and safety requirements of the directives. You’ll need to consider testing the products for compliance if you’ll change their design or characteristics. This will also apply if there are changes to the respective legislation and/or the harmonised standards to ensure compliance.