Jan 30, 2025 · CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required …

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet …

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A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European …

Manufacturers play a vital role in ensuring that products placed on the extended single market of the EEA are safe. It is their responsibility to carry out the conformity assessment, set up the …

Mar 31, 2025 · How can you prepare the technical documentation? Which information should be included in the technical documentation? How to draft the EU declaration of conformity. …

‘CE marking’ means a marking by which the manufacturer indicates that the radio equipment is in conformity with the applicable requirements set out in Union harmonisation legislation …

简而言之,问题2 所述的全部种类的COVID-19 体外诊断检测,只要符合《98/79/EC指令》第1(2)(b) 条的定义,就必须标附CE 标志,以证明其符合《98/79/EC指令》的相关适用规定,才得以投放欧 …

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Jan 6, 2025 · The purpose of the European Medicines Agency's (EMA) certification scheme for human and veterinary medicines is to confirm the medicine's marketing authorisation status …