Development and implementation of product law risk assessment procedures – service provided by the international expert

Risk assessment in the context of product law is the systematic process of identifying, analyzing and evaluating risks associated with products before they are placed on the market. It is a key element in ensuring the safety and compliance of products with applicable regulations. Details of this process are provided below.

Risk assessment is a process that involves:

• Identification of potential risks: identification of all possible risks that may occur in connection with the use of the product, its production, transportation or distribution.
• Risk analysis: determining the probability of occurrence of each identified risk and assessing the possible effects on the health of users, the environment and other stakeholders.
• Risk assessment: compilation of the results of the analysis to determine whether the risk is acceptable or requires further action to reduce or eliminate it.

Risk assessment plays a key role in product law for several reasons:

• Ensuring safety: a risk assessment identifies potential hazards and minimizes the risk of placing unsafe products on the market. This helps protect human health and the environment.
• Regulatory compliance: many EU directives and regulations (e.g., Machinery Directive, Medical Device Regulation, REACH Regulation) require risk assessments to be conducted before a product is placed on the market. Compliance with these regulations is crucial to the legality of companies’ operations.
• Protecting the company’s reputation: conducting a sound risk assessment and implementing appropriate countermeasures allows companies to avoid legal and reputational problems in the event of product safety incidents.
• Basis for decision-making: risk assessments provide the information needed to make informed decisions about the design, production and marketing of products.

The risk assessment process in the context of product law can be divided into several key stages:

1. Information gathering: gathering data on the product, its application, operating conditions and potential hazards.
2. Hazard identification: identification of any factors that may pose a risk to users or the environment, including aspects related to design, production and distribution.
3. Risk analysis: assessing the likelihood of each identified risk and its potential consequences. Various methods can be used in this step, such as qualitative and quantitative analysis.
4. Risk assessment: based on the analysis, it is decided whether the risk is acceptable or requires minimization measures.
5. Risk management: the development of a risk management strategy, which may include modifying the design, adding safeguards, introducing warning measures or changing the production process, among other things.
6. Monitoring and review: regular monitoring of risk assessment results and review of procedures to adapt to changing regulations and market conditions.

Risk assessment in the context of product law is an essential tool to ensure product safety and regulatory compliance. It helps companies identify and minimize potential risks, which translates into protection of public health and the environment, and builds trust among consumers. Reliably conducting risk assessments is critical to the success and legality of operations in the manufacturing industry.

About the expert

Mr. Lars is a distinguished Creative Mechanical Engineer and Industrial Designer with over 20 years of expertise in product development, regulatory compliance, and project management. Drawing from his strong foundation in the medical device industry, where strict regulations like MDR 2017/745 set a high bar, Mr. Lars brings a meticulous and adaptable approach to compliance with frameworks such as the General Product Safety Regulation (GPSR 2023/988). His experience spans various sectors, including outdoor equipment, household products, and medical instruments, enabling him to tailor solutions that align with unique business needs.

Renowned for his ability to take ideas from concept to global markets, Mr. Lars combines deep technical expertise with a user-centered design philosophy. He excels in navigating complex regulatory landscapes, ensuring product designs meet international standards such as CE marking, GDPR, ISO 13485, and ISO 9001. Additionally, his ability to crystallize business ideas has helped secure funding for numerous successful projects.

With a proven track record of managing large-scale, multidisciplinary projects and a collaborative approach to problem-solving, Mr. Lars has earned the trust of companies worldwide. His dedication to quality, usability, and compliance positions him as a leader in bringing innovative, user-focused solutions to market.