the European market By placing the CE marking on a product, a manufacturer is declaring, on their sole responsibility, conformity with all of the legal requirements to achieve CE marking....
Self Cerification ; Limited to the harmonized products ; It can now issue reports using external agencies or its own testing equipment. ; Archival requirement (The documents need to be archived for 10 years after the discontinuation of the product.)
Intertek offers guidance on navigating the CE Certification process, helping manufacturers meet all necessary CE Marking requirements while accessing EU markets
Applicable Items · The Medical Device Directive is applicable to devices according to the definition of ‘medical device’. A medical device is a machine, device, equipment, material, or other article used alone or in combination that contains software intended for human use as intended by the manufacturer. · Is applicable to diagnosis, prevention, monitoring, treatment or alleviation, diagnosis, monitoring, treatment of disease or alleviation or compensation for injury or disability, inve...
The medical AI company CorelineSoft announced on the 28th that it has simultaneously received European CE MDR (Medical Device Regulation) and UKCA (UK Conformity Assessed) certification. This marks...
The CE marking is a sign of product certification, indicating that the product complies with relevant European directives.
European Union Certification CE Certification In the EU market, the "CE" mark is a mandatory certification mark. According to the... Ships from China.
Directives and Amplifying Documents ; RCD.pdf · [131.42 Kb] ; Directive 2003/44/EC Amending the Recreational Craft Directive and Comments to the Directive Combined · [617.41 Kb] ; CC Papers · [857.15 Kb]
Looking for CE Marking Conformity Certification for Europe Service: Prices by MASTCERT? Bilingual Local Support. Wide Range of Expertise. Own testing laboratory.
The presence of the logo (from French, "conformité européenne" meaning "European conformity") on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. : 58 It is not a quality in...