Product compliance plays a central role in the global economy. Companies must ensure that their products comply with the applicable legal and regulatory requirements. A lack of product compliance can lead to significant legal consequences and financial losses. To prevent these risks, many companies rely on the expertise of a product compliance lawyer. This ensures that products meet the respective regulations both nationally and internationally.

An effective Product Compliance Management System (PCMS) is based on several central elements that should integrate every system, regardless of the specific company structure.

1. Corporate culture: The culture in the company significantly influences the effectiveness of the PCMS. Important aspects are corporate values that shape legal and regulatory behaviour, as well as an open error culture. To this end, clear codes of conduct should be implemented and binding communication in the supply chain should be promoted.
2. Objectives: It is important to define clear, measurable objectives for the PCMS and to regularly review and adjust them. The main objective is to comply with all regulatory requirements throughout the entire product life cycle. This includes all stages from development and production to distribution and decommissioning.
3. Risk management: A robust risk management system continuously identifies and assesses product compliance risks. The aim here is to identify potential violations at an early stage so that structured measures can be developed to minimise the risks. Regularly monitor the effectiveness of these measures.
4. Programme: The PCMS programme encompasses all actions and processes necessary to ensure product compliance. Integrate these into your existing processes and adapt them as needed, particularly in risk management, quality management and compliance.
5. Organisation: Clear organisational measures are required to effectively implement the PCMS. Define relevant roles and responsibilities and ensure that employees receive appropriate training so that they can efficiently fulfil their product compliance tasks.
6. Communication and training: Internal and external partners must be informed about the importance of product compliance. Training measures should raise employees’ awareness and help them understand the importance of complying with binding obligations.
7. Monitoring and improvement: Monitor the PCMS regularly and risk-based to verify its effectiveness. Use existing control structures and document deviations. Implement clear corrective and improvement measures to address any deficiencies identified.

A well-implemented PCMS not only protects against legal risks, but can also be used as a strategic advantage to successfully meet market challenges.

A product compliance lawyer is the right point of contact when it comes to understanding and implementing the legal framework. He helps companies to comply with the regulations in different markets to ensure that their products can be distributed without problems. Especially in the area of international markets, product compliance is a challenge because different countries have different requirements. An experienced product compliance lawyer knows the relevant laws and standards and helps to minimise liability risks and ensure market access.

A product compliance lawyer performs a wide range of tasks that are essential for compliance with legal requirements, such as:

1. Analysing product requirements: A lawyer checks which specific directives and standards apply to the respective product.
2. Risk assessment: Identifying potential liability risks associated with the production and distribution of products.
3. Documentation and certification: Assisting with the preparation of necessary documents and certificates for the international market.
4. Design and implementation of a PCMS: As part of compliance advice, the lawyer helps to set up a compliance management system to ensure that legal requirements are met on an ongoing basis.
5. Audits and internal investigations: Audits are conducted regularly to ensure compliance with all regulations. Internal investigations, on the other hand, are conducted on an ad hoc basis and are carried out when there is suspicion of rule violations or compliance violations.

Comprehensive product compliance is not only a legal requirement, but also a competitive advantage. By enlisting the expertise of a product compliance lawyer, companies can ensure that their products are brought to market in compliance with the rules, thus avoiding expensive litigation.

An experienced product compliance lawyer faces a variety of challenges. A key challenge is identifying and implementing the specific requirements in the PCMS. This also includes creating and managing the relevant documentation for senior management.

The lawyer must ensure that all material legal issues are addressed to reliably ensure product compliance. This includes, in particular, a legal review of product development and manufacturing processes.