RISK ASSESSMENT FOR NEW REGULATION (EU)2023/988 (GPSR)

The following aspects are considered for the risk assessment:

1. Hazard identification and risk analysis

• Identification of all possible hazards that can arise from the product (e.g. mechanical, electrical, thermal, chemical hazards, and others)

• Consideration of the intended use, but also foreseeable misuse and the relevant user group

• Determination and presentation of the injury scenario

2. Risk assessment

• Assessment of the probability of occurrence of the hazards, taking into account exposure factors such as frequency and duration of exposure.

• Assessment of the possible severity of the injuries or damage to health.

• Based on the analysis, the risk is classified

• The risk assessment must be carried out systematically and documented.

• In particular, the intended use of the product, but also foreseeable misuse, must be taken into account.

3. Risk reduction

• Based on the risk assessment, manufacturers must take appropriate protective measures to reduce the risks to an acceptable level. These include design measures, inherent construction methods, warnings and instructions for use.

4. Documentation

• Documentation of the entire risk assessment process.

• Retention of documents as proof of conformity.

5. Ongoing review

• The risk assessment is a continuous process that must be regularly reviewed and updated throughout the product development process, especially if there are changes to the product or new findings on hazards.

Our direct risk assessment service for you covers point 1 above.

We can assist you with points 2 and 3 with our testing services. With a customized offer and tailored tests from us, you can make your product risk tangible and take measures against specific hazards, such as harmful substances used or defects in structural integrity.

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