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CERTIFICATION

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One-stop facility for the voluntary or regulatory certification of products, management systems and services, LNE proposes an internationally-renowned and comprehensive offering of product / service / management system certifications. Thanks to such a facility, you'll be able to optimize the scheduling of audits, their time period, number and cost.

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Certification
CE marking of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD)
Any medical device, accessory, non-medical product (Annex XVI) or in vitro diagnostic medical device must comply with the requirements of European Regulations (EU) 2017/745 or (EU) 2017/746 in order to be placed on the market in the European Union. The intervention of a notified body is required for certain devices, depending on their risk class, in accordance with Annex VII of the aforementioned Regulations.

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