CE consultation services include:
- Product definition/guideline clarification
- Standards research
- Conformity evaluation (risk assessment, ...)
- Safety concept development
- Assuming authorised documentation representative tasks
- Training
Here the procedure is characterised by defining the product's application range and intended use and reasonable foreseeable misuses. Limits with regard to space and time etc. must be determined. Subsequent guideline clarification and standards research allow the implementation of a sound risk assessment as a core element in the conformity evaluation.
CE marking
Products that are subject to EC directives must be checked within the context of a conformity evaluation process for compliance with the requirements of the respective applicable EC directives and then provided with the CE marking. The prerequisite is compliance with all of the currently applicable safety and health requirements of the respective EC directive(s) in the design and production of the product. In principle, the manufacturer always applies the CE marking. Labelling a product with the EC conformity marking generally requires that a conformity evaluation be implemented and an EC conformity declaration be issued and that the required documentation be compiled.
Conformity evaluation
In a conformity evaluation, a product is checked for compliance with the respective applicable EC directive(s). Compliance with the EC directives means that all of the requirements of the EC directive(s) are met. The manufacturer is obligated to perform a conformity evaluation. Conformity evaluation procedure:
- Product definition/guideline clarification
- Standards research
- Implementation of risk assessment
- Determination of measures for reducing risk
- Checking the effectiveness of the measures
- Type approval test, if required or desired
- Preparation of operating instructions
- Compilation of technical documentation
- Issuance of conformity declaration
- Application of CE marking
Risk assessment
Risk assessment is a systematic procedure for considering risks during product development. Certain EC directives (for machinery, medical devices, etc.) expressly require that a risk assessment be performed. A risk assessment is a prerequisite for safe products and for reasons of product liability, it must be performed. A risk assessment helps to systematically determine the hazards associated with a machine or system while the product is in the development phase. It is an important instrument in the conformity evaluation and a component of the technical documentation. Risk assessment procedure:
- Specification or determination of intended use and reasonably foreseeable misuse
- Specification of product limits
- Identification of hazards
- Assessment and evaluation of risks
- Development of measures for reducing risk
- Safety concept preparation
- Checking the effectiveness of the measures
Legal foundation - EC Machinery Directive as an example
In the EC Machinery Directive 2006/42/EC, recital 23 requires that:
“The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures”. And in Appendix I, GENERAL PRINCIPLES:
1. The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment. By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:
- Determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof
- Identify the hazards that can be generated by the machinery and the associated hazardous situations
- Estimate the risks, taking into account the severity of possible injury or damage to health and the probability of its occurrence
- Evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive
- Eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2 (b)