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Why is it Important for Medical Devices to Have the CE Mark?

on April 26, 2023

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Why is it Important for Medical Devices to Have the CE Mark?

CE certification G&M Compliance Videos

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What Are Harmonized Standards And How Do They Affect the CE Mark?

Harmonized standards are technical specifications set by European agencies that, when aligned with a product directive, set compliance standards for a given product. Harmonized standards are voluntary, but following the right harmonized standard is the best way to obtain the CE Mark. Meeting the requirements of an applicable harmonized standard gives your product a “presumption of conformity” to the essential requirements for the CE Mark. In other words, if you can prove your product meets the harmonized standard, you can demonstrate compliance with the relevant product directive. Harmonized standards are developed and managed by three European standards organizations: ● European Committee for Standardization (CEN) - consolidates national standardization bodies for 34 European countries and creates European Standards (ENs) and other technical documents for a wide range of products ● European Committee for Electrotechnical Standardization ( CENELEC ) - pro

Common Directives Applicable For the CE Mark

An important indicator of a product’s compliance with EU legislation, CE marking enables free movement of your products inside the European market. A small sign affixed on your product declares its conformity with all legal requirements needed to get the CE marking. Getting your products certified will make sure that you are legally able to sell these across the EEA, in 27 member states in the European Free Trade Association countries such as Turkey, Iceland, Norway and Liechtenstein—as well as the rest of EU. Ensure Free Movement of Your Goods CE marking directives cover a number of manufacturing concerns and products. The most recent CE marking directives include: Radio and Telecommunications Terminal Equipment 99/5/EC Those new Approach Directives that do not require CE Marking are: Packaging and Packaging Waste 94/62/EC High Speed Rail Systems 96/48/EC Construction Products 89/106/EEC Machinery 98/37/EC (amended 98/79/EC) Lifts 95/16/EC It is

What is a Field Evaluation and Why Do You Need It?

A field evaluation is a type of inspection performed on equipment that is already installed in the field. This kind of evaluation looks to see if equipment and its performance meets applicable safety standards for its real-world location and application. Field evaluations are done on equipment that does not have a current certification or applicable report from a Nationally Recognized Testing Laboratory, such as UL, CSA, or TUV. This field evaluation may be requested by a local electrical inspector, utility, or a client looking for specific assurances of equipment safety and performance. Field evaluations are common for large electrical systems like industrial control panels (ICP), switchboards, panelboards, or termination boxes. These onsite inspections are also helpful for other industrial or large systems, such as heating and cooling systems, commercial cooking equipment, robotic equipment, and automated manufacturing or packaging systems. There are a few reasons that a fi

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