Earlier this year, the European Commission released the latest references for the harmonized standards used to demonstrate conformity with the EU EMC Directive 2004/108/EC and the new R&TTE Directive 1999/5/EC requirements started on January 1, 2015. (R&TTE is replaced in June 2016 by the Radio Equipment Directive (RED) 2014/53/EC).
Placed on many categories of products, CE Marking is mandatory for machinery, electrical and electronic equipment, medical devices, hazardous location equipment, and other products. So if you are looking to sell an electronics product in the EU, you will need to apply a CE mark.
Here’s a Top 12 list of interesting facts about CE marking:
- The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985
- CE stands for Conformité Européenne (French), which means European conformity
- CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements
- With a CE mark, your product can be sold in the EU and in Iceland, Liechtenstein, and Norway
- There are six steps to CE marking: 1. Identify the relevant directives and standards, 2. Verify the product’s specific requirements, 3. Identify whether an independent conformity assessment (Notified Body) is necessary, 4. Test product, 5. Create technical documentation, and 6. Add CE mark to the product
- CE marking is not evidence of compliance – your technical documentation/technical file is
- The manufacturer or authorized representative must keep technical documentation for a number of years (the number is dependent on the product type) after the last product has been placed on the market
- Each EU country is responsible to enforce CE marking, by banning products and levying fines for non-compliance
- Unsafe products are shared in the EU via RAPEX – a rapid alert system on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers
- There is a very similar logo where the CE stands for Chinese Export or China Export – this has nothing to do with European conformity
- The size of the CE mark must be at least 5 mm high. If the appearance or size of a product do not allow for the CE marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents
- Pre-testing early in the product development process can reduce cost and time to market
MET Labs has tested thousands of products to support CE Marking Declarations of Conformity (DoC) for product safety, electromagnetic compatibility, and energy efficiency. Contact us today to tap the experience and skill of the MET engineering team.
The European Commission is contemplating developing an “eCompliance System” and has published a “Preliminary Reflections on eCompliance” paper on how it would work. Following is a summary of this report that was distributed at the May 2014 meeting of the Group of Notified Bodies under the EMC Directive (EUANB) in Amsterdam.
As products become more complex while product cycles become shorter, the Commission believes it is necessary to explore how compliance with Union harmonisation legislation can be demonstrated/controlled electronically (“eCompliance” concept) instead of the traditional paper-based approach.
The primary objective is to maintain protection of the public interest, while reducing the administrative burden for manufacturers (especially SMEs), Notified Bodies, and authorities.
In an eCompliance context, the process of demonstrating compliance would become more interactive: manufacturers and other operators, Notified Bodies (if involved in the conformity assessment procedure) and authorities would share information and provide real-time feedback to each other.
This may lead to a situation where the border between conformity assessment (ex-ante control) and market surveillance (ex-post control) would not be so clearly defined – authorities may have the opportunity to monitor a product before it is placed on the market.
Various tools (e.g. e-labelling, digital market surveillance, electronic declarations of conformity, etc.) could function in all official Union languages and improve communication:
- Between authorities and manufacturers
- Between authorities and Accreditation/Notified Bodies and between Accreditation/Notified Bodies themselves
- Between authorities
Commercial secrets and confidentiality aspects would be protected by a system of access authorizations.
In order to avoid the proliferation of IT tools, the Commission would examine whether the eCompliance System should be part of the Information and Communication System on Market Surveillance (ICSMS).
Planning for an eCompliance System in Europe is still very preliminary, with many questions to be answered and stakeholders to be consulted. Subscribe to Compliance Today to be kept apprised on further developments in this area.
To product safety and electromagnetic compatibility compliance, add another regulatory hurdle for electronics manufacturers. To assure “conflict minerals” are not imported from the Democratic Republic of Congo and neighboring conflict areas, Securities and Exchange Commission (SEC) registered companies will have to start documenting the source and purpose of Congo-related raw materials.
The affected minerals include:
- Tin (cassiterite)
- Coltan (columbite-tantalie)
- Tungsten (wolf-ramite)
- Any other mineral the U.S. Secretary of State wants to add
From coltan, tantalum is extracted and used to manufacture electronic capacitors. It can be found in video game systems, cell phones, digital cameras, CD players, computers and pacemakers. Tungsten is used to make cell phones vibrate and the biggest use of tin worldwide is in electronics on circuit boards.
The exact timing of when compliance to this Title XV provision of the recently-passed Dodd-Frank Wall Street Reform and Consumer Protection Act isn’t known, although the act stipulates that regulations must be finalized by April 2011. Prior to that, there will be a public comment period. In the meantime, the SEC is soliciting unofficial public comment here.
National security applications have up to a two-year exemption.
Do you think this new data collection requirement is justified, or is it just a political move that adds an unnecessary regulatory hurdle?