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

on March 13, 2023

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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 Electrotechn...

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 ...

Benefits working with G&M Compliance to obtain your EAC Certification

Brief summary of EAC Certification In effect since August 2013, the Eurasian Conformity Certification (EAC) has been used by the Eurasian Economic Union (EAEU) to signify products imported through the EAEU are safe and meet the required standards. It consists of the following countries; Russia, Armenia, Belarus, Kazakhstan, and Kyrgyztan. Prior to the introduction of the EAC certification, Russia has been using the GOST-R mark to demonstrate compliance with national regulations. The EAC mark is now use to demonstrate compliance for not only Russia, but also other Eurasian countries, promoting free trade in the area and streamlining requirements for international manufacturers. The EAEU single market includes 183 million consumers and a GDP of more than $4 trillion (USD). There are many different types of products that are required by law to have an EAC mark if you are planning to import to the Eurasian Economic Union. Keep up to date by visiting the official site, Eurasian E...

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