What is CE Marking?
The CE Marking of a product is a declaration of compliance with the regulations governing the relevant safety standards, according to the European directive that applies to them.
Special Conditions of the CE Marking Service
- The CE Marking product certification service is an exclusive service for our R&D consulting and prototype manufacturing clients.
- The price of the CE Marking service includes design changes that are part of the resulting recommendations.
- We work hand in hand with trusted CE laboratories, who advise us and share critical information for product design.
Do you need to know what certifications your invention requires? Let's talk!
We prepare and process the CE marking for innovative products.
- We identify the European regulations and safety directives that apply to your innovative product.
- We design and manufacture prototypes in compliance with the CE Marking directives.
- Redesign of products and optimization of prototypes in compliance with CE directives.
- We work hand in hand with laboratories that issue CE in Spain and Italy.
What products are required to comply with the CE Marking?
Most innovative products require CE marking to be marketed in Europe. We can help you determine if your product needs CE marking.
📲 CE Marking for Electronic Devices. CE Marking 2014/30/EU
The design and development of innovative electronic products is a core activity of our invention manufacturing laboratory. This clear specialization has made us very familiar with the European standard or EU regulation 2014/30.
In addition to the basic safety requirements demanded by the European standard, to achieve the CE marking under EU regulation 2014/30, special attention is given to electromagnetic compatibility.
All innovative electronic products, such as household appliances, power tools, and other similar items, must comply with such regulations.
⚙️ CE Marking for Innovative Machines. CE Marking 2006/42/EC
For the design and manufacturing of machine prototypes, it is crucial to understand the basic principles of the 2006/42/EC directive for CE marking.
The CE marking of innovative machines is stringent regarding statements of operation and safe functioning. Typically, these machines undergo very rigorous safety tests to validate such statements and protect the manufacturer from liabilities.
👉 CE Marking for Toys. CE Regulations 88/378/EEC and 2009/48/EC
The CE Regulations 88/378/EEC and 2009/48/EC refer to the safety directives or standards for toys in Europe.
CE 88/378/EEC: This regulation established the first safety standards, primarily focusing on mechanical restrictions of toys, provisions regarding electronic toys, and the regulation of chemical elements used.
In the case of Directive 2009/48/EC, it is an update to the previous toy regulation. This standard focuses primarily on risk assessments of toys, as well as the accuracy of their labeling.
📡 CE Marking for Radio Equipment and Telecommunications Terminal Equipment. CE Marking 2014/53/EU
The development of IoT products is part of our core as a innovative product development agency. This industrial revolution, aimed at the evolution of radio equipment, leads us to pay special attention to what is dictated in the European Directive 2014/53/EU.
IoT products require CE marking. They are typically subject to various directives, not just the CE 2014/53 standard.
Based on our experience, for an IoT product to obtain CE marking, it must undergo electrical safety tests, electromagnetic compatibility, wireless communication tests, cybersecurity, environmental and mechanical safety, as well as energy efficiency tests.
🛠️ CE Marking for Construction Products. CE Marking EU 305/2011
Most innovative construction products are subject to the CE Marking – EU 305/2011 standard.
This European regulation focuses on ensuring compliance with safety standards for these products, particularly regarding their mechanical strength and sustainability.
⛑️ CE Marking for Personal Protective Equipment. CE Marking EU 2016/425
Many inventions from our clients aim to improve the most common personal protective equipment. In this case, protection products are regulated by the CE Marking regulation 2016/425.
The content of the EU 2016/425 standard focuses on defining a set of risk categories, associated with mandatory parameters for products that aim to be sufficient in this area.
🏥 CE Marking for Medical Devices. CE Marking 93/42/EEC
The development of innovative medical products is a priority among our clients. The directives for CE Marking for medical devices define a set of categories based on risk association. In the CE 93/42/EEC standard, the categories are distinguished as: I, class IIa, and class III.
Medical devices associated with class III must be evaluated by a special body to obtain the CE Marking.
💧 CE Marking for Domestic and Industrial Boilers. CE Marking 92/42/EEC
The great need for optimization of conventional energy resource systems, the innovation in boilers and hydraulic systems, is more than common in our product laboratory.
The innovative products in this category are regulated by the CE Marking directives, specifically the CE 92/42/EEC standard. This standard was also updated in 2013 by the CE marking 813/2013 directive, which added restrictions on ecology and efficiency.
🫁 CE Marking for Active Implantable Medical Devices. CE Marking 90/385/EEC
Implantable products are those that coexist, either fully or partially, in the human body. For example, medical devices such as bone implants, measuring and diagnostic devices, pacemakers, insulin pumps, or other similar products.
The CE 93/42/EEC marking, as previously described, refers to other medical products that are never inserted into the human body.
At Let’s Prototype, we work on the design and development of medical prototypes, especially prototypes for diagnostics, that capture data from the human body and transmit it remotely to the cloud and analysis environments.
🤒 In vitro Diagnostic Medical Devices. CE Marking 98/79/EC
The pursuit of improving users' health, facilitating early disease detection, and minimizing manufacturing costs of diagnostic instruments are perfect ingredients for many companies and inventors to focus on the development of in vitro diagnostic medical devices.
En esta categoría de productos sanitarios, de cada al marcado CE, incluye algunos muy conocidos como: pruebas e embarazo o los test para detectar el VIH.
At Let’s Prototype, during the critical moment of COVID-19, we developed several medical prototype examples that required the 98/79/EC certification.
💥 CE Marking for Civil Use Explosives. CE Marking 2014/28/EU
At Let’s Prototype, we have no experience working with this type of product. However, we know that the CE Marking 2014/28/EU standard makes special mention of the need to maximize safety, traceability, and especially handling criteria for these types of solutions.
Other Products That Require CE Marking.
- Recreational Boats. CE Marking 2013/53/EU
- Elevators. CE Marking 2014/33/EU
- Pressure Equipment. CE Marking 2014/68/EU
- Cableway Passenger Transport Installations. CE Marking 2000/9/EC
- Custom-made Instruments. CE Marking 2006/42/EC
- Low Voltage. CE Marking 2014/35/EU
- Pyrotechnic Articles. CE Marking 2007/23/EC and 2013/29/EU
- Weighing Instruments. CE Marking 2014/31/EU
- Simple Pressure Vessels. CE Marking 2014/29/EU
- Gas Appliances. CE Marking 2016/426
- Imported Products. CE Marking
Method to certify your invention with the CE Marking
1. Identification of the standard
2. Prototype or design settings
3. Laboratory tests
4. Review of the CE certificate
CE Marking Information
What is CE marking for?
The CE marking summarizes the mandatory regulations with which most products must comply in order to be marketed in the countries that are part of the European Community.
Who issues the CE certificate?
The CE certificate is issued by bodies and laboratories certified by AENOR. The process consists of the identification of standards that regulate the products and the application of tests and trials that make up the applicable regulations. The standards include lists of applicable test types according to the category of products being certified.
If the product has CE components, is it certified?
The use of CE certified components does not guarantee that the product complies with the certification. The recommended procedure is to identify the standard that affects you and submit it to the tests and experiments that are included in the standard that affects you according to your category.
What kind of tests are done to obtain the CE marking?
The tests or trials to obtain the CE marking are very varied, it depends on the type of product. Destructive tests to check mechanical resistance of parts and pieces, dimension checks that guarantee safety to users, radioactivity control, tests on dangerous cavities with risk of entrapment, are some of the frequent tests to obtain the CE marking.
How long does it take to get the CE marking?
The testing process to achieve CE marking can take between 4 and 6 weeks. This period refers to the time of application of tests in approved laboratories. On the other hand, the times that take the longest are those linked to the identification of the standard, analysis of tests, preparation of the product and management of appointments to submit the product to the tests that affect it to obtain the CE marking. In Let's Prototype, we have achieved complete processes in 3
How much does it cost to certify a CE marked product?
The price to obtain the CE marking varies, the usual costs in the laboratory range between € 3,000 and € 4,000, however, there are products that require fewer tests and the price decreases. Even so, to this price we must add the value of the consulting process, which includes the identification and study of the CE regulations that affect the product. Also, it is common for inventors to hire not only the CE certification service, but also the guarantee of necessary adjustments in the prototype to prepare it for testing.
Do products manufactured in China have CE Marking?
It is recommended that you manufacture the first prototype units in an identical way to how future manufacturing will be, regardless of whether you do it in China or other countries. The important thing is that you submit to tests units identical to those you are going to market. It is important that when you buy parts and pieces or components in China or Marketplace like Amazon, do not settle for them saying that they meet CE standards, you must ask for the certificate. Surprisingly, many products sold in Europe through these channels claim to comply with the standard, but do not have a CE certificate to prove it.
Is CE Marking useful for medical prototypes?
Medical products usually have their own regulations, depending on their use. Some require a very rigorous testing process that exceeds in complexity the tests normally proposed to achieve CE standards. It is important in these cases not to skip the step of studying applicable regulations, since in most products or prototypes for medical use it is not enough with the CE Marking.
The time to bring your ideas to life is now. We accompany you throughout the entire process: from idea to product.
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