easyCE CE project checklist: You need this data for CE labelling and technical documentation.
- Which product information and data are required for conformity assessment? Which for product analysis, which for risk assessment?
- Every product requires complete and correct operating instructions or instructions for use in order to fulfil the product safety requirements. What information and data is required for this?
- The following checklist lists the information and data that the easyCE experts will request from you in order to be able to carry out the conformity assessment of your product correctly.
Checklist of required information
| Information | Product analysis | Risk assessment | Operating instructions |
|---|---|---|---|
| General view (graphics) of the machine/product | 1 | 0 | 1 |
| For the cover page: Photo or graphic of the product | 0 | 0 | 1 |
| Detailed views (graphics) of the machine/product with all operator - machine/product interfaces (What does the operator need to know? Where does the operator need to go?) | 0 | 0 | 1 |
| Components of the machine/product with exact designations of the parts that the operator must access | 1 | 1 | 1 |
| Area of application (commercial, private) | 1 | 1 | 1 |
| Scope of delivery | 1 | 0 | 1 |
| Variants of the machine/product, if applicable | 1 | 1 | 1 |
| Take as many photos/videos as possible on site (not for the documents, but for better understanding) | 0 | 0 | 0 |
| Technical data (weight, dimensions, power supply, performance, other connections such as compressed air, etc., materials, accuracies, interfaces, etc.) | 1 | 1 | 1 |
| What materials does the machine/product need/process? | 1 | 1 | 1 |
| Exact contact details of the manufacturer, if necessary also for service, maintenance,... | 1 | 1 | 1 |
| Company logo of the manufacturer | 1 | 1 | 1 |
| Terminology | 1 | 1 | 1 |
| Target group of the product/operating instructions (prior knowledge) | 1 | 1 | 1 |
| Functionality/ functional description | 1 | 1 | 1 |
| Intended/unintended use | 1 | 1 | 1 |
| Ambient conditions under which the machine/product may be used | 1 | 1 | 1 |
| Emissions, especially for machines (noise, dust, heat, cold, vibrations, electromagnetic fields, etc.) with test reports | 1 | 1 | 1 |
| Pictograms/ instructions affixed to the machine/product by the manufacturer | 1 | 1 | 1 |
| Danger areas | 1 | 1 | 1 |
| Safety devices (EMERGENCY STOP,...) | 1 | 1 | 1 |
| Nameplate: where is it attached? What information is included? | 1 | 0 | 1 |
| Operating modes (automatic, expert user,...), if applicable | 1 | 1 | 1 |
| Transport/ installation/ commissioning: What does the manufacturer do? What is the operator responsible for? | 0 | 1 | 1 |
| Operation: User interface of panel, control panel, remote control etc.: Screenshots, graphics,... | 0 | 0 | 1 |
| Information on operation (procedure, action steps, consequences, dangers) | 0 | 1 | 1 |
| List of (error) messages, meaning of the message, measures | 1 | 1 | 1 |
| Maintenance: what may/must the operator do, what must the manufacturer do (service)? | 1 | 1 | 1 |
| Maintenance intervals | 0 | 0 | 1 |
| Spare parts list with article numbers | 0 | 0 | 1 |
| Service life of the machine/product | 1 | 1 | 1 |
| Disposal: are there any components that require special disposal (radioactivity, hazardous substances, etc.)? | 1 | 1 | 1 |
| Documents/drawings that should/must be included in the operating instructions (circuit diagrams, flow charts, component lists, system architecture, etc.) | 1 | 1 | 1 |
| Is a quick reference guide required? For what purpose (format, waterproof, weatherproof,...)? | 0 | 0 | 1 |
| Supplier information | 1 | 1 | 1 |
| Information on comparable devices (optional) | 1 | 1 | 1 |
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Sources:
[1] Wolfram W. Pichler, EU conformity assessment in archt project phases straight to the goal, The recipe book for designers, product managers and CE coordinators, 2018
[2] Hans-Joachim Hess & Tom Gördes, Produkthaftung in Deutschland und Europa, das Praxishandbuch für Unternehmer und Führungskräfte - mit Fallbeispielen, Mustern und Checklisten, second revised edition, 2019
[3] Michael Loerzer, Peter Buck, Andreas Schwabedissen, Rechtskonformes Inverkehrbignen von Produkten. In 10 steps to the declaration of conformity, 2nd updated and expanded edition, Beuth
[4] Jörg Ertelt, Basic knowledge of CE marking, CE marking in Europe and the rest of the world. Who is affected by CE labelling?
[5] Wikipedia, European Economic Area, Aug. 2020, https://de.wikipedia.org/wiki/Europ%C3%A4ischer_Wirtschaftsraum