EU Market Access for Electrical Equipment
Do you have a product ready for deployment in the European market? Every company or entity that trades electrical equipment in the European market is required to obtain a CE-mark. CE-Mark is proof that your equipment conforms with all legal requirements of the European market. As the responsible party, you must comply with the set of requirements and processes known as The Low Voltage Directive 2004/35/EU. The directive ensures that the equipment is safe to the user and will help you obtain the CE-Mark, after which you can introduce your medical equipment to the European market.
Other Requirements:
Depending on the specifics of your product, it might be possible that your electrical equipment has to comply with more directives. Products that contain electronics have to fulfill substance and waste directives and have other disposal measures. Additionally, you must comply with Radio Equipment Directive 2014/53/EU if your electrical equipment contains Bluetooth or radio functions. We can help classify your product for you. You might also have to comply with the following directives:
- Restriction of Hazardous Substances Directive
- Waste Electrical and Electronic Equipment
- Eco-label
- Electromagnetic Compatibility
Access the EU Market: Our Assistance:
Your electrical equipment and its documentation need to comply with the EU directives. Every case is unique and requires an approach according to its attributes. We guarantee your electrical equipment to meet all mandatory requirements by offering a certification process that is quick and customized according to your needs. If you are unsure which directives your product needs to comply with as a medical electrical device, we can provide a confirmation service. We will handle everything after you provide specific information about your product and guarantee that your electrical equipment complies with the requirements.
What is Electromagnetic Compatibility (EMC)
Electromagnetic compatibility, known as “EMC”, is the ability of Electrical and Electronic (E&E) equipment to operate within its electromagnetic (EM) environment and with other equipment. All E&E devices have the potential to emit electromagnetic field radio frequency (RF) interference. Such interference can affect the normal operation of devices and others within their environment and is therefore subject to measurement and control.
The purpose of EMC is two-fold:
- To ensure that electronic devices operate as intended in their electromagnetic environment without causing Electromagnetic Interference (EMI) with each other (or themselves)
- To ensure that radio communications, particularly for emergency services, are protected
We can also support in testing or gap analysis over already performed tests. Reach out
How do we work?
We review your current documentation and testing to assess the level of compliance. We guide and help to prepare any missing documentation or cover any gaps. We liaison with selected test labs and notified bodies to help you get your products smoothly into the market. We offer Auth. Rep. support so you have a single contact point to deal with your CE compliance matters.
CE Mark Services
- Product Documentation Review
- Compliance Gap Assesments
- Liason with Notified Bodies
- Appointing of EU Auth. Rep.
- Creation support of Technical File
- Selection of Lab and performance of testing
- EC Declaration Of Conformity
Price and Time
Price and time depend of the type of product and the current status of your documentation. We have a direct connection with notified bodies and accredited test labs in Europe and also in Asia. This helps us to streamline the process and speed up the CE marking authorization. Fill in the quick form to get a quote straight away!