Global requirements and trade barriers, new EU requirements such as CRA, MVO, DPP, and EPA (are you familiar with these acronyms?), technical norms and standards—how should companies position themselves to successfully bring products to market?
There are significant differences between countries such as the U.S. or China on the one hand and the EU on the other. Outside the EU, product certification systems are very commonly relied upon. In contrast, the EU’s approach, based on the “New Approach” (CE marking), differs considerably.
It is not uncommon to hear that the pace and density of regulation in the EU are so substantial that they become a noticeable obstacle.
Example: additional documentation requirements when no harmonized standards listed in the OJEU are available. In this case, the manufacturer must document how it nevertheless meets the relevant essential requirements.
Compliance versus Risk
As a result, the issue of “compliance versus risk” takes center stage when it comes to product compliance: Was it specified in sufficient detail during the requirements phase which legal and technical standards (or deviations from them) apply to the product in the respective target markets? This begins with the distinction between the EU-27 and other European countries such as Serbia or the post-Brexit “UK.” And in Material Compliance, unlike “technical product compliance,” there are few technical standards and thus more legal requirements—in some cases extending down to the state level (U.S., Canada).
It is striking that responsibilities within companies are sometimes insufficiently defined. For example, in medium-sized and large companies, EU declarations of conformity are rarely signed by the managing directors, even though they bear legal responsibility. The signing is delegated, for example, to product managers, who in turn do not verify the accuracy of the content with the necessary thoroughness. Product compliance audits reveal that invalid harmonized standards or other standards were cited for years. In these cases, there was no established process to determine who, within the framework of internal production control, would have been responsible for assessing the implications of the successor standards (EN ISO, EN IEC).
Assuming Responsibility for Roles and Activities in the Product Lifecycle
Every employee who plays a role in the product lifecycle contributes, within their area of responsibility, to ensuring that a legally compliant product is placed on the market. The associated activities should be clearly defined in each case. Here are three representative examples:
- The purchasing department has procurement responsibilities and, when purchasing materials or more complex assemblies, should know what to look for in supplier declarations of RoHS compliance—and not just focus on price. Activity: Verifying the authenticity of the submitted documents, e.g., in accordance with DIN EN IEC 63000.
- The design department is responsible for ensuring that designs are created in accordance with the state of the art and current scientific knowledge. Task: Technical norms and standards should be researched, obtained (observe “license compliance”!), read, interpreted, and applied appropriately.
- The sales department bears sales responsibility. It is easy to say that products should be sold worldwide. But are the relevant legal regulations and technical (where applicable, national) standards—and their differences from EU standards—also known? Task: Identify specific countries, determine relevant legal regulations and standards, and derive appropriate measures.
In this context, legal experts refer to the obligation to organize operations in relation to the marketability of products. What this specifically means for the organization and processes related to product compliance is, in some cases—despite widespread ISO 9001 certification—insufficiently regulated or reduced to a mere formality, for example, when existing product compliance managers are overruled by other decision-makers.
This is where the challenge lies for the coming years: identifying internal weaknesses and establishing effective, efficient, and—above all—sustainable processes that ensure the company’s success in product sales. Only then is a product compliance management system effective.
Francine Dammholz, Linda Kritzler, Manfred Böhm, and Michael Loerzer have explored the future of product compliance and compiled these insights in a new book.
→ Pre-order “Product Compliance Management” from NOMOS (in German)
Do you have questions about product compliance management systems? We’re happy to provide further assistance. Simply send us an email with your question or use our contact form.
Author's note
This article has been machine translated into English.
