Frequently at F2 Labs we get very deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking required.
There is no reason to feel any apprehension. We help customers to comply with CE marking requirements every day. We also help customers understand that some requirements foisted upon the project by a buyer are not even legally required.
Below is a list of some very common questions asked all the time by our customers who are new to CE marking. This list was drafted to send out to our customers at the start of a project. I thought it could be useful as an article for our blog. We hope this is helpful, please see below.
CE marking Overview – Frequently Asked Questions
Summary:
- Placing a CE marking on your equipment means that you are making a claim that your product complies with any EU CE Directive that applies to your equipment.
- The manufacturer places the CE marking, it is not issued by a testing laboratory.
- Self-certification means that you, as the manufacturer, can place the CE marking without having a test lab place the marking (as is case with North American safety compliance, i.e., “Listings”). In most cases this will require technical intervention by an accredited 3rd party laboratory, like F2 Labs.
- Your product must be accompanied by an EU Declaration of Conformity, or in some cases, a Declaration of Incorporation for Partly Completed Machinery.
- In all cases you are required to compile and maintain a Technical File at your facility for ten years after you ship the last product to the EU.
- The Technical File must contain the proof that your equipment complies with the applicable Directives. In almost all cases that will require Technical Reports prepared by an accredited 3rd party lab.
- Only the authorities in the EU have a right to see your Technical File. You are not obligated to deliver the technical file to your customer as a part of CE marking compliance.
The Directives:
- The Machinery Directive (MD) 2006/42/EC, is applicable to machinery, broadly defined as anything with linked components that move under other-than-human power. Some lifting apparatus and attachments for machinery are also included as is lifting devices that rely on human power.
- The EMC Directive 2014/30/EU is applicable to anything with active electronics.
- The Medical Device Directive (MDD) 93/42/EEC is applicable to medical devices.
- The Low Voltage Directive (LVD) 2014/35/EU is applicable to any product with an input voltage of 50 – 1,000 VAC or 75 – 1,500 DC.
- The Radio Equipment Directive (RED) 2014/53/EU is applicable to all equipment with any wireless function. It also makes the technical requirements of the LVD automatically applicable, regardless of voltage.
- The Pressure Equipment Directive (PED) 2014/68/EU is applicable to any product with a pressure of .5 bar and above but there are numerous exclusions.
- The ATEX Directive 2014/34/EU is applicable to equipment that operates in a potentially explosive atmosphere. However, explosive risks generated in your machinery are covered by the Machinery Directive 2006/42/EC.
- The Restriction of Hazardous Substances Directive (RoHS) 2011/65/EU is applicable to any device with any electric power or function. This means even a device with a piezo ignitor button.
F2 Labs is here to help.
Please call us at 877-405-1580.