2025年1月30日 · Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet …

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. The conformity assessment usually involves an audit of the …

CE marking is a part of the EU’s harmonisation legislation, which is mainly managed by Directorate-General for Internal market, Industry, Entrepreneurship and SMEs. The CE …

EU rules on CE markings for different sectors, how to get a CE marking, rules and standards for importers and distributors. CE marking Information on CE marking in EU countries, how to …

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 …

2023年10月20日 · 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 is a mark that manufacturers use to indicate that a product meets relevant European Union (EU) legal conformity standards in terms of safety, health and environmental protection. …

Before placing a device on the market, the manufacturer will affix the CE mark in accordance with Annex V and draw up the EU declaration of conformity, including all the information required …

The Protocol makes certain provisions of EU law applicable also to and in the United Kingdom in respect of Northern Ireland. In particular, the Protocol provides that EU legislation requiring the …

CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by the applicable EU harmonisation legislation. It is not …