By affixing the CE Marking, the manufacturer, or its representative, or the importer assures that the item meets all the essential requirements of all applicable EU directives. As a Worldwide Authorized Independent Agency, Medilink offers conformity assistance with Construction Products, Containers, Cranes, Electrical Products and Components, Electromagnetic Compatibility (EMC), Lifts, Marine Equipment, Materials, Mechanical Products, Process Machines, Pressure equipment, Personal Protective Equipment (PPE), Telecom, Toys and Wood. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, etc…can further reduce timescales and costs.
Key Benefits of CE Marking Certification
- Access the world’s second largest importer (and largest exporter)
- It is mandatory to understand your obligations and demonstrate compliance
- Working with a Compliance Provider from project concept helps reduce project life cycle timescales and budget
- Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R,ROHS etc…can further reduce timescales and costs
Our Approach of CE Marking
One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage. At Medilink, we can assist with the entire life cycle of a product from design and development, supply and production, distribution and delivery, to retail distribution and even final dismantling or destruction.
Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, what are your quality expectations?
The responses help us to identify the regulatory barriers, the directives, the standards, your conformity assessment route option, etc...And to develop a rationalised compliance plan for your product range with your target markets within, as well as outside, the EU
Scope of Directives CE Marking
Medilink boasts the following Notified and Competent Body appointments
Medical Device Directive – 93/42/EEC
- Low Voltage Device Directive – 2006/95/EC
- Machinery Directive – 2006/42/EC
- Construction Product Regulation – (EU) 305/2011
- Electromagnetic Compatibility Directive – 2004/108/EC
- Pressure Equipment Directive – 97/23/EC
- Simple pressure vessels Directive - 87/404/EEC
- Personal Protective Equipment Directive - 89/686/EEC
Why Choose Medilink for CE Marking Certification?
For over 5 years, we have worked successfully with leading Electrical and Electronic, Construction, Machinery, Medical Devices product manufacturers, importers, and operators around the world to help them better manage risk and assure regulatory compliance. The reassurance of consulting an officially recognized conformity assessment body like Medilink is invaluable. With dedicated and experienced approvals engineers in every major sourcing area worldwide, we offer you the convenience of global coverage with local service where you need it. Our staff participates in the development of international, industry and regulatory standards worldwide, keeping you and us at the forefront of changes in the various approvals requirements and certification methods.
Together, we acknowledge your desire to create a product that is aesthetically pleasing as well as safe, reliable, high performance and efficient. Providing you with the highest levels of service is a priority for us.