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Medical Device Directives. In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices, the In Vitro Diagnostics Directive (IVDD) 98/79/EC.. These CE marking Directives cover active
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For example, there are rules for medical devices, machines with moving parts, electronic devices, etc. If you want to sell a product in one of these categories anywhere in the European Union, your product must meet the standards set by the rules. If your product meets the standards, it can bear a CE marking and be sold in the EU.
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No matter the size of your organization, SGSs medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.
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The EC declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information
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